The CathPilot: Performance Validation and Preclinical Safety and Feasibility Assessment.

OBJECTIVES: Peripheral endovascular revascularization procedures often fail due to technical limitations of guidewire support, steering, and visualization. The novel CathPilot catheter aims to address these challenges. This study assesses the safety and feasibility of the CathPilot and compares its performance to conventional catheters for peripheral vascular interventions. METHODS: The study compared the CathPilot to non-steerable and steerable catheters. The success rates and access times for a relevant target inside a tortuous vessel phantom model were assessed. The reachable workspace within the vessel and the guidewire's force delivery capabilities were also evaluated. To validate the technology, chronic total occlusion tissue samples were used ex vivo to compare crossing success rates with conventional catheters. Finally, in vivo experiments in a porcine aorta were conducted to evaluate safety and feasibility. RESULTS: The success rates for reaching the set targets were 31%, 69%, and 100% with the non-steerable catheter, the steerable catheter, and the CathPilot, respectively. CathPilot had a significantly larger reachable workspace, and allowed for up to four times higher force delivery and pushability. In crossing of chronic total occlusion samples, the CathPilot achieved a success rate of 83% and 100%, for fresh and fixed lesions respectively, which was also significantly higher than conventional catheters. The device was fully functional in the in vivo study, and there were no signs of coagulation or damage to the vessel wall. CONCLUSION: This study shows the safety and feasibility of the CathPilot system and its potential to reduce failure and complication rates in peripheral vascular interventions. The novel catheter outperformed conventional catheters in all defined metrics. This technology can potentially improve the success rate and outcome of peripheral endovascular revascularization procedures.

Health utility in community-dwelling adults with dysvascular lower limb loss.

PURPOSE: Adults with dysvascular lower extremity amputation (LEA) experience a large number of secondary health conditions yet there is a gap in the literature on health utility scores for this population. A health utility score relates to a person's state of well-being, and is a single metric anchored at 0 (death) and 1 (perfect health). This study aimed to provide a descriptive account of health utility scores in community-dwelling adults with dysvascular LEA. METHODS: Participants were adults with dysvascular LEA who were 3 months post-amputation. Data collected included socio-demographic characteristics, the Special Interest Group in Amputee Medicine (SIGAM) grades, the dysvascular conditions scale (DCS), which is a scale developed for this study, and the Short Form-36 (SF-36). SF-6D health utility scores were derived from the SF-36 using a software algorithm. Participants were grouped into low-impact and high-impact groups based on self-reported severity of symptoms using the DCS. Health utility scores were compared between the low-impact and high-impact groups using independent t-tests. RESULTS: A total of 231 participants were enrolled in the study. The mean SF-6D health utility score was 0.689 (0.127). A significant association was found between health utility score and SIGAM grade (p < 0.001, η2 = .09). Health utility was positively associated with age (r = 0.137, p = 0.037) and months post-amputation (r = 0.141, p = 0.032), and negatively associated with DCS severity (r = -0.526, p < 0.001). Health utility scores were lower for participants in the DCS high-impact groups for conditions such as diabetes mellitus, phantom limb pain, musculoskeletal pain, back pain, psychological distress, depression, vision problems, and other pain. CONCLUSION: Cost-utility analyses rely on health utility estimates and our findings provide data for future economic evaluations that may assist policy makers in evidence informed allocation of healthcare resources for this population.

Geographical socioeconomic disadvantage is associated with adverse outcomes following major amputation in diabetic patients.

OBJECTIVE: Socioeconomic disadvantage is a known predictor of adverse outcomes and amputation in patients with diabetes. However, its association with outcomes after major amputation has not been described. Here, we aimed to determine the association of geographic socioeconomic disadvantage with 30-day readmission and 1-year reamputation rates among patients with diabetes undergoing major amputation. METHODS: Patients from the Maryland Health Services Cost Review Commission Database who underwent major lower extremity amputation with a concurrent diagnosis of diabetes mellitus between 2015 and 2017 were stratified by socioeconomic disadvantage as determined by the area deprivation index (ADI) (ADI1 [least deprived] to ADI4 [most deprived]). The primary outcomes were rates of 30-day readmission and 1-year reamputation, evaluated using multivariable logistic regression models and Kaplan-Meier survival analyses. RESULTS: A total of 910 patients were evaluated (66.0% male, 49.2% Black), including 30.9% ADI1 (least deprived), 28.6% ADI2, 19.1% ADI3, and 21.2% ADI4 (most deprived). After adjusting for differences in baseline demographic and clinical factors, the odds of 30-day readmission was similar among ADI groups (P > .05 for all). Independent predictors of 30-day readmission included female sex (odds ratio [OR], 1.45), Medicare insurance (vs private insurance; OR, 1.76), and peripheral artery disease (OR, 1.49) (P < .05 for all). The odds of 1-year reamputation was significantly greater among ADI4 (vs ADI1; OR, 1.74), those with a readmission for stump complication or infection/sepsis (OR, 2.65), and those with CHF (OR, 1.53) or PAD (OR, 1.59) (P < .05 for all). CONCLUSIONS: Geographic socioeconomic disadvantage is independently associated with 1-year reamputation, but not 30-day readmission, among Maryland patients undergoing a major amputation for diabetes. A directed approach at improving postoperative management of chronic disease progression in socioeconomically deprived patients may be beneficial to reducing long-term morbidity in this high-risk group.

Evaluating Quality Metrics and Cost After Discharge: A Population-based Cohort Study of Value in Health Care Following Elective Major Vascular Surgery.

BACKGROUND: Early readmission to hospital after surgery is an omnipresent quality metric across surgical fields. We sought to understand the relative importance of hospital readmission among all health services received after hospital discharge. OBJECTIVE: The aim of this study was to characterize 30-day postdischarge cost and risk of an emergency department (ED) visit, readmission, or death after hospitalization for elective major vascular surgery. METHODS: This is a population-based retrospective cohort study of patients who underwent elective major vascular surgery - carotid endarterectomy, EVAR, open AAA repair, bypass for lower extremity peripheral arterial disease - in Ontario, Canada, between 2004 and 2015. The outcomes of interest included quality metrics - ED visit, readmission, death - and cost to the Ministry of Health, within 30 days of discharge. Costs after discharge included those attributable to hospital readmission, ED visits, rehab, physician billing, outpatient nursing and allied health care, medications, interventions, and tests. Multivariable regression models characterized the association of pre-discharge characteristics with the above-mentioned postdischarge quality metrics and cost. RESULTS: A total of 30,752 patients were identified. Within 30 days of discharge, 2588 (8.4%) patients were readmitted to hospital and 13 patients died (0.04%). Another 4145 (13.5%) patients visited an ED without requiring admission. Across all patients, over half of 30-day postdischarge costs were attributable to outpatient care. Patients at an increased risk of an ED visit, readmission, or death within 30 days of discharge differed from those patients with relatively higher 30-day costs. CONCLUSION: Events occurring outside the hospital setting should be integral to the evaluation of quality of care and cost after hospitalization for major vascular surgery.

Peripheral artery disease among Indigenous Canadians: What do we know?

Indigenous Canadians experience a disproportionate burden of chronic atherosclerotic diseases, including peripheral artery disease (PAD). Despite an estimated prevalence of 800 000 patients with PAD in Canada, the burden of the disease among Indigenous Canadians is unclear. Available evidence suggests that this population has a higher prevalence of several major risk factors associated with PAD (diabetes, smoking and kidney disease). Unique socioeconomic, geographic and systemic obstacles affecting Indigenous Canadians' health and health care access may worsen chronic disease outcomes. Little is known about the cardiovascular and limb outcomes of Indigenous peoples with PAD. A novel approach via multidisciplinary vascular health teams engaging Indigenous communities in a culturally competent manner may potentially provide optimal vascular care to this population. Further research into the prevalence and outcomes of PAD among Indigenous Canadians is necessary to define the problem and allow development of more ffective initiatives to alleviate the disease burden in this marginalized group.

Au Canada, les membres des communautés autochtones sont affectés de manière disproportionnée par les maladies athéroscléreuses chroniques, y compris par l'artériopathie périphérique (AP). Malgré une prévalence estimée de 800 000 patients atteints d'AP au Canada, on ignore quel est le fardeau de la maladie chez les membres des communautés autochtones. Selon les données accessibles, cette population présente une prévalence plus élevée de plusieurs facteurs de risque majeurs associé à l'AP (diabète, tabagisme et maladie rénale). Certains obstacles socioéconomiques, géographiques et systémiques particuliers nuisent aussi à leur santé et leur compliquent l'accès aux soins de santé, ce qui pourrait aggraver les répercussions des maladies chroniques. On en sait peu sur l'issue des problèmes cardiovasculaires et circulatoires périphériques chez les membres des communautés autochtones touchés par l'AP. Une approche nouvelle, impliquant les communautés concernées et offerte de manière culturellement compétente par des uipes de santé vasculaire multidisciplinaires, serait propice à la prestation de soins vasculaires optimaux. Il faudra approfondir la recherche sur la prévalence et l'issue de l'AP chez les membres des communautés autochtones pour cerner le problème et permettre la mise en place d'initiatives plus efficaces afin d'alléger le fardeau de la maladie dans ce groupe marginalisé.

Under-representation of women and ethnic minorities in vascular surgery randomized controlled trials.

OBJECTIVES: Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes. Although well studied in other fields, balanced enrollment of patients with relevant demographic characteristics in vascular surgery randomized controlled trials (RCTs) is not well known. This study describes the reporting of gender and ethnicity data in vascular surgery RCTs and analyzes whether these studies adequately represent our diverse patient population. METHODS: We conducted a retrospective review of United States-based RCTs from 1983 through 2007 for three broadly defined vascular procedures: aortic aneurysm repair (AAR), carotid revascularization (CR), and lower extremity revascularization (LER). Included studies were examined for gender and ethnicity data, study parameters, funding source, and geographic region. The Nationwide Inpatient Sample (NIS) database was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population. RESULTS: We reviewed 77 studies, and 52 met our inclusion criteria. Only 85% reported gender, and 21% reported ethnicity. Reporting of ethnicity was strongly associated with larger (>280 participants), multicenter, government-funded trials (P < .001 for all). Women are disproportionately under-represented in RCTs for all procedure categories (AAR, 9.0% vs 21.5%; CR, 30.0% vs 42.9%; LER, 22.4% vs 41.3%). Minorities are under-represented in AAR studies (6.0% vs 10.7%) and CR studies (6.9% vs 9.5%) but are over-represented in LER studies (26.0% vs 21.8%, P < .001 for all). CONCLUSIONS: Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCTs, particularly in small, non-government-funded and single-center trials. The generalizability of some trial results may not be applicable to these populations. Greater effort to enroll a balanced study population in RCTs may yield more broadly applicable results.