Vaso-Lock for sutureless anastomosis in a pig arteriovenous loop model.

A vascular anastomosis is a critical surgical skill that involves connecting blood vessels. Traditional handsewn techniques can be challenging and resource intensive. To address these issues, we have developed a unique sutureless anastomotic device called Vaso-Lock. This intraluminal device connects free vascular ends using anchors to maintain traction and enable a rapid anastomosis. We tested the anastomotic capability of Vaso-Locks in a pig common carotid-internal jugular arteriovenous model. The use of Vaso-Lock allowed us to accomplish this procedure in less than 10 min, in contrast to the approximately 40 min required for a handsewn anastomosis. The Vaso-Lock effectively maintained patency for at least 6 weeks without causing significant tissue damage. Histological analysis revealed that the device was successfully incorporated into the arterial wall, promoting a natural healing process. Additionally, organ evaluations indicated no adverse effects from using the Vaso-Lock. Our findings support the safety and effectiveness of the Vaso-Lock for arteriovenous anastomosis in pigs, with potential applicability for translation to humans. Our novel sutureless device has the potential to advance surgical practice and improve patient outcomes.

5-Year Follow-Up of a Physician Performance Feedback Report Intervention to Reduce Overuse and Excess Cost: A National Cohort Study.

BACKGROUND: Mohs micrographic surgery efficiently treats skin cancer through staged resection, but surgeons' varying resection rates may lead to higher medical costs. OBJECTIVE: To evaluate the cost savings associated with a quality improvement. MATERIALS AND METHODS: The authors conducted a retrospective cohort study using 100% Medicare fee-for-service claims data to identify the change of mean stages per case for head/neck (HN) and trunk/extremity (TE) lesions before and after the quality improvement intervention from 2016 to 2021. They evaluated surgeon-level change in mean stages per case between the intervention and control groups, as well as the cost savings to Medicare over the same time period. RESULTS: A total of 2,014 surgeons performed Mohs procedures on HN lesions. Among outlier surgeons who were notified, 31 surgeons (94%) for HN and 24 surgeons (89%) for TE reduced their mean stages per case with a median reduction of 0.16 and 0.21 stages, respectively. Reductions were also observed among outlier surgeons who were not notified, reducing their mean stages per case by 0.1 and 0.15 stages, respectively. The associated total 5-year savings after the intervention was 92 million USD. CONCLUSION: The implementation of this physician-led benchmarking model was associated with broad reductions of physician utilization and significant cost savings.

Appropriateness of Care Measures: A Novel Approach to Quality.

The clinical judgement of a physician is one of the most important aspects of medical quality, yet it is rarely captured with quality measures in use today. We propose a novel approach using individualized physician benchmarking that measures the appropriateness of care that a physician delivers by looking at their practice pattern in a specific clinical situation. A prime application of our novel approach to appropriateness measures is the surgical management of peripheral artery disease and claudication. We discuss 4 potential consensus metrics for the treatment if claudication that explore appropriateness of care of claudication management, and are meaningful, actionable, and quantifiable. Given the multitude of medical specialties involved in the care of patients with peripheral artery disease, and the consequences of both preemptive and delayed care, it is in all of our interests to promote data transparency with confidential communications to outlier physicians while advocating for evidence-based management.

Utility of Motor Evoked Potentials in Contemporary Open Thoracoabdominal Aortic Repair.

OBJECTIVES: Paraplegia remains one of the major complications of contemporary open thoracoabdominal aortic aneurysm (TAAA) repair. Intraoperative motor-evoked potentials (MEPs) act as a surrogate measure for spinal cord homeostasis. The purpose of this study was to evaluate the results of intraoperative neuromonitoring in contemporary TAAA repair and its association with postoperative spinal cord ischemia. METHODS: Patients who underwent open type 2 or 3 TAAA or completion aortic repair utilizing intraoperative neuromonitoring were identified between May 2006 and November 2023. Patient demographics, comorbidities, indication for the procedure, procedural details, and outcomes were recorded. The groups were divided based on type of repair, and univariate statistics were then utilized to evaluate the association of these metrics versus the type of repair. RESULTS: Seventy-nine patients underwent open type 2 (N=41) and 3 (N=23) TAAA and completion aortic (N=15; open in 14, endovascular in 1) repairs by a single surgeon. The cohort was predominantly male (N=48, 60.8%) with a mean age of 52.5±16.2 years. There was a high incidence of hypertension (N=53, 67.1%), smoking history (N=42, 53.1%), and connective tissue disorders (N=37, 46.8%). Operative indications included dissection-related (N=50, 63.3%) and degenerative (N=26, 32.9%) TAAA and dissection-related malperfusion (N=3, 3.8%). Left heart bypass was often (N=73, 92.4%) utilized for distal aortic perfusion, and cerebrospinal fluid drainage (N=77, 97.5%) was a common adjunct. MEPs were classified as no change (N=43, 54.4%), reversible change (N=26, 32.9%), irreversible change (N=4, 5.1%), and unreliable (N=6, 7.6%). MEP changes were predominantly bilateral (N=70, 88.6%) and occurred most often during repair of the abdominal aortic segment (N= 13, 16.5%). The median number of replaced vertebral levels was associated with MEP changes (P=0.013). SCI was only observed in repairs greater than 6 replaced vertebral levels with an overall frequency of 17.7%. It was most prevalent in completion aortic repairs (26.7%). Immediate and delayed SCI occurred in 10.1% and 7.6% of patients, respectively; it was most commonly (71.8%) reversible. Permanent paraplegia occurred in 4 patients (5.1%), with equal immediate and delayed onsets. MEPs demonstrated poor sensitivity (53.9%) and specificity (62.3%) for SCI, however there was a high negative predictive value (86.4%) in this population. In-hospital mortality occurred in 5 (6.3%). CONCLUSIONS: No changes in intraoperative MEPs are highly predictive of spinal cord homeostasis. The number of replaced vertebral levels and previous aortic repair should guide intraoperative neuroprotective measures including intercostal reimplantation and should take precedence over intraoperative monitoring, especially when MEP changes occur.

Self-Rated Health in Middle Age and Risk of Hospitalizations and Death: Recurrent Event Analysis of the ARIC Study.

BACKGROUND: Self-rated health is a simple measure that may identify individuals who are at a higher risk for hospitalization or death. OBJECTIVE: To quantify the association between a single measure of self-rated health and future risk of recurrent hospitalizations or death. PARTICIPANTS: Atherosclerosis Risk in Communities (ARIC) study, a community-based prospective cohort study of middle-aged men and women with follow-up beginning from 1987 to 1989. MAIN MEASURES: We quantified the associations between initial self-rated health with risk of recurrent hospitalizations and of death using a recurrent events survival model that allowed for dependency between the rates of hospitalization and hazards of death, adjusted for demographic and clinical factors. KEY RESULTS: Of the 14,937 ARIC cohort individuals with available self-rated health and covariate information, 34% of individuals reported "excellent" health, 47% "good," 16% "fair," and 3% "poor" at study baseline. After a median follow-up of 27.7 years, 1955 (39%), 3569 (51%), 1626 (67%), and 402 (83%) individuals with "excellent," "good," "fair," and "poor" health, respectively, had died. After adjusting for demographic factors and medical history, a less favorable self-rated health status was associated with increased rates of hospitalization and death. As compared to those reporting "excellent" health, adults with "good," "fair," and "poor" health had 1.22 (1.07 to 1.40), 2.01 (1.63 to 2.47), and 3.13 (2.39 to 4.09) times the rate of hospitalizations, respectively. The hazards of death also increased with worsening categories of self-rated health, with "good," "fair," and "poor" health individuals experiencing 1.30 (1.12 to 1.51), 2.15 (1.71 to 2.69), and 3.40 (2.54 to 4.56) times the hazard of death compared to "excellent," respectively. CONCLUSIONS: Even after adjusting for demographic and clinical factors, having a less favorable response on a single measure of self-rated health taken in middle age is a potent marker of future hospitalizations and death.

Patient decision-making in the era of transcarotid artery revascularization.

OBJECTIVE: The National Coverage Determination on carotid stenting by Medicare in October 2023 stipulates that patients participate in a shared decision-making (SDM) conversation with their proceduralist before an intervention. However, to date, there is no validated SDM tool that incorporates transcarotid artery revascularization (TCAR) into its decision platform. Our objective was to elicit patient and surgeon experiences and preferences through a qualitative approach to better inform the SDM process surrounding carotid revascularization. METHODS: We performed longitudinal perioperative semistructured interviews of 20 participants using purposive maximum variation sampling, a qualitative technique designed for identification and selection of information-rich cases, to define domains important to participants undergoing carotid endarterectomy or TCAR and impressions of SDM. We also performed interviews with nine vascular surgeons to elicit their input on the SDM process surrounding carotid revascularization. Interview data were coded and analyzed using inductive content analysis coding. RESULTS: We identified three important domains that contribute to the participants' ultimate decision on which procedure to choose: their individual values, their understanding of the disease and each procedure, and how they prefer to make medical decisions. Participant values included themes such as success rates, "wanting to feel better," and the proceduralist's experience. Participants varied in their desired degree of understanding of carotid disease, but all individuals wished to discuss each option with their proceduralist. Participants' desired medical decision-making style varied on a spectrum from complete autonomy to wanting the proceduralist to make the decision for them. Participants who preferred carotid endarterectomy felt outcomes were superior to TCAR and often expressed a desire to eliminate the carotid plaque. Those selecting TCAR felt it was a newer, less invasive option with the shortest procedural and recovery times. Surgeons frequently noted patient factors such as age and anatomy, as well as the availability of long-term data, as reasons to preferentially select one procedure. For most participants, their surgeon was viewed as the most important source of information surrounding their disease and procedure. CONCLUSIONS: SDM surrounding carotid revascularization is nuanced and marked by variation in patient preferences surrounding autonomy when choosing treatment. Given the mandate by Medicare to participate in a SDM interaction before carotid stenting, this analysis offers critical insights that can help to guide an efficient and effective dialog between patients and providers to arrive at a shared decision surrounding therapeutic intervention for patients with carotid disease.

Associations Between Prior Head Injury, Physical Functioning, and Frailty in the Atherosclerosis Risk in Communities Study.

BACKGROUND: Older adults have the highest rates of head injury and are at the greatest risk for subsequent dysfunction, yet research on subsequent physical decline is limited. We sought to examine cross-sectional and prospective associations of head injury with physical functioning and frailty among older adults. METHODS: A total of 5 598 Atherosclerosis Risk in Communities Study participants from Visit 5 (2011-13) underwent assessments of physical functioning (Short Physical Performance Battery [SPPB], comprised of gait speed, chair stands, and balance) and frailty (defined using established criteria) were followed through Visit 7 (2018-19). Head injury was self-reported or based on ICD-9 codes. Adjusted linear and multinomial logistic regression models were used to estimate associations. Prospective models incorporated inverse probability of attrition weights to account for death or attrition. RESULTS: Participants were a mean age of 75 years, 58% were women, 22% were Black, and 27% had a prior head injury. Compared to individuals without head injury, individuals with head injury had worse physical functioning (SPPB total score, ß-coefficient = -0.22, 95% CI: -0.35 to -0.09) and were more likely to be pre-frail (OR = 1.19, 95% CI: 1.04 to 1.35) or frail (OR = 1.40, 95% CI: 1.08 to 1.80) compared to robust. Prospectively, head injury was associated with a 0.02 m/s greater decline (95% CI: -0.04 to -0.01) in gait speed over a median of 5 years. Among baseline robust individuals (n = 1 847), head injury was associated with increased odds of becoming pre-frail (OR = 1.32, 95% CI: 1.04 to 1.67) or frail (OR = 1.92, 95% CI: 1.05 to 3.51) compared to robust. CONCLUSIONS: Older adults with prior head injury had worse physical functioning and greater frailty at baseline and were more likely to become frail and walk slower over time, compared to individuals without head injury.

Representation of Women and Racially and Ethnically Marginalized Principal Investigators in Vascular Device Trials.

This quality improvement study describes the lack of diversity in trial leadership, especially in arterial disease device trials, and recommends action steps.

Implementation of a novel peer review academy by Surgery and the Association of Women Surgeons.

BACKGROUND: A novel Peer Review Academy was developed as a collaborative effort between the Association of Women Surgeons and the journal Surgery to provide formal training in peer review. We aimed to describe the outcomes of this initiative using a mixed methods approach. METHODS: We developed a year-long curriculum with monthly online didactic sessions. Women surgical trainee mentees were paired 1:1 with rotating women surgical faculty mentors for 3 formal peer review opportunities. We analyzed pre-course and post-course surveys to evaluate mentee perceptions of the academy and assessed changes in mentee review quality over time with blinded scoring of unedited reviews. Semi-structured interviews were conducted upon course completion. RESULTS: Ten women surgical faculty mentors and 10 women surgical trainees from across the United States and Canada successfully completed the Peer Review Academy. There were improvements in the mentees' confidence for all domains of peer review evaluated, including overall confidence in peer review, study novelty, study design, analytic approach, and review formatting (all, P ≤ .02). The mean score of peer review quality increased over time (59.2 ± 10.8 vs 76.5 ± 9.4; P = .02). In semi-structured interviews, important elements were emphasized across the Innovation, Implementation Process, and Individuals Domains, including the values of (1) a comprehensive approach to formal peer review education; (2) mentoring relationships between women faculty and resident surgeons; and (3) increasing diversity in the scientific peer review process. CONCLUSION: Our novel Peer Review Academy was feasible on a national scale, resulting in significant qualitative and quantitative improvements in women surgical trainee skillsets, and has the potential to grow and diversify the existing peer review pool.

Investigating the impact of suboptimal prescription of preoperative antiplatelets and statins on race and ethnicity-related disparities in major limb amputation.

BACKGROUND: Non-Hispanic Black and Hispanic patients with symptomatic PAD may receive different treatments than White patients with symptomatic PAD. The delivery of guideline-directed medical treatment may be a modifiable upstream driver of race and ethnicity-related disparities in outcomes such as limb amputation. The purpose of our study was to investigate the prescription of preoperative antiplatelets and statins in producing disparities in the risk of amputation following revascularization for symptomatic peripheral artery disease (PAD). METHODS: We used data from the Vascular Quality Initiative, a vascular procedure-based registry in the United States (2011-2018). We estimated the probability of preoperative antiplatelet and statin prescriptions and 1-year incidence of amputation. We then estimated the amputation risk difference between race/ethnicity groups that could be eliminated under a hypothetical intervention. RESULTS: Across 100,579 revascularizations, the 1-year amputation risk was 2.5% (2.4%, 2.6%) in White patients, 5.3% (4.9%, 5.6%) in Black patients, and 5.3% (4.7%, 5.9%) in Hispanic patients. Black (57.5%) and Hispanic patients (58.7%) were only slightly less likely than White patients (60.9%) to receive antiplatelet and statin therapy. However, the effect of antiplatelets and statins was greater in Black and Hispanic patients such that, had all patients received these medications, the estimated risk difference comparing Black to White patients would have reduced by 8.9% (-2.9%, 21.9%) and the risk difference comparing Hispanic to White patients would have been reduced by 17.6% (-0.7%, 38.6%). CONCLUSION: Even though guideline-directed care appeared evenly distributed by race/ethnicity, increasing access to such care may decrease health care disparities in major limb amputation.

Risks and Benefits of the Proposed Amputation Reduction and Compassion Act for Disadvantaged Patients.

Racial, ethnic, and socioeconomic disparities in the major risk factors for vascular disease and access to vascular specialist care are well-documented.1-3 The higher incidence of diabetes, peripheral artery disease (PAD), and related nontraumatic lower extremity amputation among racial and ethnic minority groups, those of low socioeconomic status, and those with poor access to care based on geography (together, referred to below as disadvantaged groups) are particularly pervasive.1,4-9 Practitioners of vascular surgery and endovascular therapy are uniquely positioned to address health inequities in lower extremity screening, medical management, intervention, and limb preservation among the population of adults at the highest risk for limb loss.

Automatic 1-year follow-up appointment creation and reminders can improve long-term follow-up after carotid revascularization.

BACKGROUND: Long-term follow-up (LTFU) following carotid revascularization is important for post-surgical care, stroke risk optimization and post-market surveillance of new technologies. METHODS: We instituted a quality improvement project to improve LTFU rates for carotid revascularizations (primary outcome) by scheduling perioperative and one-year follow-up appointments at time of surgery discharge. A temporal trends analysis (Q1 2019 through Q1 2022), multivariable regression, and interrupted time series (ITS) were performed to compare pre-post intervention LTFU rates. RESULTS: 269 consecutive patients were included (151 pre-intervention, 118 post-intervention; mean 71 â€‹± â€‹12 years-old, 39% female, 77% White). The overall LTFU rate improved (64.9%-78.8%; P â€‹= â€‹0.013) after the intervention. After controlling for patient factors, procedures performed after the intervention were associated with increased odds of being seen for 1-year follow-up (OR: 2.2 95%CI: 1.2-4.0). Quarterly ITS analysis corroborated this relationship (P â€‹= â€‹0.01). CONCLUSIONS: Time-of-surgery appointment creation and automated patient reminders can improve LTFU rates following carotid revascularizations.

Perspectives on Lower Extremity Peripheral Artery Disease: A Qualitative Study of Early Diagnosis and Treatment and the Impact of Health Disparities.

Lower-extremity peripheral artery disease (PAD), the accumulation of atherosclerotic plaque in the arteries of the legs, causes substantial morbidity and mortality. Frequent under- and delayed diagnosis result in poor outcomes, disproportionately affecting individuals from racial and ethnic minority groups. To understand barriers to early detection and treatment and factors contributing to disparities, American Medical Group Association (AMGA) conducted roundtable discussions and semistructured interviews in 2021. Eighteen participants discussed PAD evaluation, diagnosis, early medical management, and disparities in care. A qualitative case study approach and data reduction methods were used to generate themes, draw conclusions, and make actionable recommendations. Identified themes included lack of (1) prioritization of PAD for population health; (2) engagement of primary care providers in early evaluation and referral; (3) "ownership" of lower-extremity PAD within health systems; and (4) focus on disparities in care. Participant solutions included (1) financial impact of early PAD management, in the context of value-based payment; (2) embedding an advanced practice provider into a vascular surgery practice to facilitate evaluation and provide medical therapy; and (3) leveraging care coordination, multidisciplinary clinics, and telehealth technology to provide comprehensive care for patients with PAD and address disparities. A deliberate focused effort is necessary to close gaps and the accompanying disparities in early evaluation, diagnosis, and treatment for people with lower-extremity PAD. The authors describe 3 models that can be emulated to improve care for this high-risk population. With improved reimbursement and better medical therapies, now is the time to focus on early diagnosis and management of PAD.

Mature artificial intelligence- and machine learning-enabled medical tools impacting vascular surgical care: A scoping review of late-stage, US Food and Drug Administration-approved or cleared technologies relevant to vascular surgeons.

Artificial intelligence and machine learning (AI/ML)-enabled tools are shifting from theoretical or research-only applications to mature, clinically useful tools. The goal of this article was to provide a scoping review of the most mature AI/ML-enabled technologies reviewed and cleared by the US Food and Drug Administration relevant to the field of vascular surgery. Despite decades of slow progress, this landscape is now evolving rapidly, with more than 100 AI/ML-powered tools being approved by the US Food and Drug Administration each year. Within the field of vascular surgery specifically, this review identified 17 companies with mature technologies that have at least one US Food and Drug Administration clearance, all occurring between 2016 and 2022. The maturation of these technologies appears to be accelerating, with improving regulatory clarity and clinical uptake. The early AI/ML-powered devices extend or amplify clinically entrenched platform technologies and tend to be focused on the diagnosis or evaluation of time-sensitive, clinically important pathologies (eg, reading Digital Imaging and Communications in Medicine-compliant computed tomography images to identify pulmonary embolism), or when physician efficiency or time savings is improved (eg, preoperative planning and intraoperative guidance). The majority (>75%) of these technologies are at the intersection of radiology and vascular surgery. It is becoming increasingly important that the contemporary vascular surgeon understands this shifting paradigm, as these once-nascent technologies are finally maturing and will be encountered with increasingly regularity in daily clinical practice.

Associations Between Head Injury and Subsequent Risk of Falls: Results From the Atherosclerosis Risk in Communities (ARIC) Study.

BACKGROUND AND OBJECTIVES: Falls are a leading cause of head injury among older adults, but the risk of fall occurring after a head injury is less well-characterized. We sought to examine the association between head injury and subsequent risk of falls requiring hospital care among community-dwelling older adults. METHODS: This analysis included 13,081 participants in the Atherosclerosis Risk in Communities Study enrolled in 1987-1989 and followed through 2019. The association of head injury (time-varying exposure, self-reported and/or ICD-9/10 code identified) with the risk of subsequent (occurring >1-month after head injury) falls requiring hospital care (ICD-9/10 code defined) was modeled using Cox proportional hazards regression. Secondary analyses included Fine and Gray proportional hazards regression to account for the competing risk of death, analysis of head injury frequency and severity, and formal testing for interaction by age, sex, and race. Models were adjusted for age, sex, race/center, education, military service, alcohol consumption, smoking, diabetes, hypertension, and psychotropic medication use. RESULTS: The mean age of participants at baseline was 54 years, 58% were female, 28% were Black, and 14% had at least one head injury occurring over the study period. Over a median 23 years of follow-up, 29% of participants had a fall requiring medical care. In adjusted Cox proportional hazards models, individuals with head injury had 2.01 (95% CI 1.85-2.18) times the risk of falls compared with individuals without head injury. Accounting for the competing risk of mortality, individuals with head injury had 1.69 (95% CI 1.57-1.82) times the risk of falls compared with individuals without head injury. We observed stronger associations among men compared with women (men: hazard ratio [HR] = 2.60, 95% CI 2.25-3.00; women: HR = 1.80, 95% CI 1.63-1.99, p-interaction <0.001). We observed evidence of a dose-response association for head injury number and severity with fall risk (1 injury: HR = 1.68, 95% CI 1.53-1.84; 2+ injuries: HR = 2.37, 95% CI 1.92-2.94 and mild: HR = 1.97, 95% CI 1.78-2.18; moderate/severe/penetrating: HR = 2.50, 95% CI 2.06-3.02). DISCUSSION: Among community-dwelling older adults followed over 30 years, head injury was associated with subsequent falls requiring medical care. We observed stronger associations among men and with increasing number and severity of head injuries. Whether older individuals with head injury might benefit from fall prevention measures should be a focus of future research.