Racial and ethnic representation in peripheral artery disease randomized clinical trials.

Clinical trial enrollment provides various benefits to study participants including early access to novel therapies that may potentially alter the trajectory of disease states. Trial sponsors benefit from enrolling demographically diverse trial participants enabling the trial outcomes to be generalizable to a larger proportion of the community at large. Despite these and other well-documented benefits, clinical trial enrollment for Black and Hispanic Americans as well as women continues to be low. Specific disease states such as peripheral artery disease (PAD) have a higher prevalence and clinical outcomes are relatively worse in Black Americans compared with non-Hispanic white Americans. The recruitment process for PAD clinical trials can be costly and challenging and usually comes at the expense of representation. Participant willingness and trust, engagement, and socioeconomic status play essential roles in the representation of under-represented minority (URM) groups. Despite the contrary belief, URM groups such as Blacks and Hispanics are just as willing to participate in a clinical trial as non-Hispanic Whites. However, financial burdens, cultural barriers, and inadequate health literacy and education may impede URMs' access to clinical trials and medical care. Clinical trials' enrollment sites often pose transportation barriers and challenges that negatively impact creating a diverse study population. Lack of diversity among a trial population can stem from the stakeholder level, where corporate sponsors of academic readers do not consider diversity in clinical trials a priority due to false cost-benefit assumptions. The funding source may also impact the racial reporting or the results of a given trial. Industry-based trials have always been criticized for over-representing non-Hispanic White populations, driven by the desire to reach high completion rates with minimum financial burdens. Real efforts are warranted to ensure adequate minorities' representation in the PAD clinical trials and to the process toward the ultimate goal of developing more durable and effective PAD treatments that fit the needs of real-world populations.

Clinical Implications of Low Body Mass Index on Endovascular Lower Extremity Revascularization.

BACKGROUND: The epidemic of obesity and associated cardiovascular morbidity continues to grow, attracting public attention and healthcare resources. However, the impact of malnutrition and being underweight continues to be overshadowed by obesity, especially in patients with peripheral arterial disease (PAD). This study assesses the characteristics and outcomes of patients with low body mass index (BMI ≤ 18.5) compared to patients with nonobese BMI undergoing peripheral vascular interventions (PVI). METHODS: A retrospective analysis of patients undergoing PVI due to PAD registered in the Vascular Quality Initiative database. Patients were categorized into underweight (BMI ≤ 18.5) and nonobese BMI (BMI = 18.5-30). Patients in both groups were matched 3:1 for baseline demographic characteristics, comorbidities, medications, and indications. Kaplan-Meier analysis was done for long-term outcomes. RESULTS: A total of 337,926 patients underwent PVI, of whom 12,935 (4%) were underweight, 215,728 (64%) were nonobese, and 109,263 (32%) were obese. Underweight patients were more likely to be older, female, smokers, with chronic obstructive pulmonary disorder, and more likely to present with chronic limb-threatening ischemia than nonobese patients. After propensity matching, there were 18,047 nonobese patients and 6,031 underweight patients. There were no significant differences in matched characteristics. Perioperatively, underweight patients were more likely to require a longer hospital length of stay. Underweight patients had statistically significantly higher 30-day mortality compared to patients with nonobese BMI (3% vs. 1.6%, P < 0.001) and a higher rate of thrombotic complications. As for long-term outcomes, underweight patients had a higher rate of reintervention (20% vs. 18%, P < 0.001) and major adverse limb events (27% vs. 22%, P < 0.001). The 4-year rate of amputation-free survival was significantly lower in underweight patients (70% vs. 82%, P < 0.001), and the 2-year freedom from major amputation (90% vs. 94%, P < 0.001) showed similar trends with worse outcomes in patients who were underweight. CONCLUSIONS: Underweight patients with PAD are disproportionally more likely to be African American, females, and smokers and suffer worse outcomes after PVI than PAD patients with nonobese BMI. When possible, increased scrutiny and optimization of nutrition and other factors contributing to low BMI should be addressed prior to PVI.

The utilization of three-dimensional imaging and three-dimensional-printed model in autologous microtia reconstruction.

Background: The use of three-dimensional (3D) technology helps surgeons in performing autologous microtia reconstruction due to more accurate measurements and a better precision template model. However, the technical aspects of using a 3D imaging and 3D-printed model and the difference in outcomes postoperatively remain poorly reviewed. Purpose: This systematic review aimed to provide the current evidence of the benefit and technical aspects of using 3D technology in autologous microtia reconstruction. Method: A systematic literature search was conducted across multiple databases: Medline, Embase, Google Scholar, and Central until June 2022. Studies that evaluated the use of 3D imaging or 3D-printed models for autogenous microtia reconstruction were selected. The quality of the included studies was also assessed with respect to the study design. Result: A systematic literature search yielded 17 articles with a combination of observational and case report studies. Overall, 3D imaging showed a precise measurement for preoperative costal cartilage assessment. Compared to the 2D template, the utilization of a 3D-printed template provided a higher similarity rate relative to the unaffected ear, higher patient and surgeon satisfaction, and lower surgical time. Most 3D templates were fabricated using polylactic acid material on fused deposition modelling printers. The template costs were ranging from $1 to $4.5 depending on the material used. Conclusion: 3D imaging and 3D-printed templates could improve the outcome of autologous microtia reconstruction. However, the quality of the existing evidence remains low due to the heterogeneity of the reported outcomes. Further studies with more adequate comparability and defined outcomes are still required.

Comparative Outcomes of Peripheral Vascular Interventions in Patients on Chronic Anticoagulation with Factor Xa Inhibitors and Vitamin K Antagonists.

BACKGROUND: In patients undergoing revascularization for peripheral arterial disease (PAD), low-dose Factor Xa inhibitors (FXaI) taken with aspirin improved limb and cardiovascular outcomes compared to aspirin alone. Furthermore, in atrial fibrillation and venous thromboembolism, FXaI are recommended over vitamin K antagonists (VKA) for chronic anticoagulation. While studies have evaluated different perioperative anticoagulation regimens in patients treated for PAD, the optimal regimen for chronic anticoagulation in patients with PAD undergoing peripheral vascular intervention (PVI) has not been determined. This analysis compares outcomes of patients after PVI that require chronic anticoagulation with FXaI and VKA. METHODS: The Vascular Quality Initiative-PVI database was used. Patients consistently treated with FXaI or VKA before the procedure, at discharge, and on long-term follow-up were defined as those receiving chronic anticoagulation. Patient demographics, procedural details, and perioperative and long-term outcomes were compared between FXaI and VKA groups. RESULTS: A total of 109,268 patients were analyzed, and 6,885 were chronically anticoagulated with FXaI (N = 2,427) or VKA (N = 4,458). Patients anticoagulated with VKA were more frequently males (65.3% vs. 61.0%, P < 0.001) with end-stage renal disease (9.7% vs. 4.6%, P < 0.001) and more likely to be treated for chronic limb-threatening ischemia (58.1% vs. 52.7%, P < 0.001). Rates of hematoma following PVI were significantly higher in patients taking VKA compared to FXaI (3.5% vs. 1.9%, P < 0.001). Multivariable logistic regression analysis showed that VKA were associated with increased perioperative hematoma than FXaI (odds ratio = 1.89 [1.30-2.82]). Compared to patients taking VKA, those receiving FXaI had lower rates of major amputation (6.7% vs. 8.4%, P = 0.020) and mortality (7.6% vs. 15.2%, P ≤ 0.001). Using Kaplan-Meier analysis, patients consistently anticoagulated with FXaI had improved amputation-free survival after PVI. Adjusting for significant patient and procedural characteristics, Cox proportional hazard regression demonstrated that there is an increased risk for major amputation or mortality in patients using VKA compared to FXaI (hazard ratio 1.61, [1.36-1.90]). CONCLUSIONS: Chronic anticoagulation with FXaI as compared to VKA was associated with superior perioperative and long-term outcomes in patients with PAD undergoing PVI. FXaI should be the preferred agents over VKA for chronic anticoagulation in patients with PAD undergoing PVI.

The Use and Impact of Cilostazol on Patients Undergoing Endovascular Peripheral Interventions.

BACKGROUND: Cilostazol is used for the treatment of intermittent claudication. The impact of cilostazol on the outcomes of peripheral vascular interventions (PVIs) remains controversial. This study assesses the use and impact of cilostazol on patients undergoing PVI for peripheral arterial disease (PAD). METHODS: The Vascular Quality Initiative (VQI) database files for PVI were reviewed. Patients with PAD who underwent PVI for chronic limb threatening-ischemia or claudication were included and divided based on the use of cilostazol preoperatively. After propensity matching for patient demographics and comorbidities, the short-term and long-term outcomes of the 2 groups (preoperative cilostazol use versus no preoperative cilostazol use) were compared. The Kaplan-Meier method was used to determine outcomes. RESULTS: A total of 245,309 patients underwent PVI procedures and 6.6% (N = 16,366) were on cilostazol prior to intervention. Patients that received cilostazol were more likely to be male (62% vs 60%; P < 0.001), White (77% vs. 75%; P < 0.001), and smokers (83% vs. 77%; P < 0.001). They were less likely to have diabetes mellitus (50% vs. 56%; P < 0.001) and congestive heart failure (14% vs. 23%; P < 0.001). Patient on cilostazol were more likely to be treated for claudication (63% vs. 40%, P < 0.001), undergo prior lower extremity revascularization (55% vs. 51%, P < 0.001) and less likely to have undergone prior minor and major amputation (10% vs. 19%; P < 0.001) compared with patients who did not receive cilostazol. After 3:1 propensity matching, there were 50,265 patients included in the analysis with no differences in baseline characteristics. Patients on cilostazol were less likely to develop renal complications and more likely to be discharged home. Patients on cilostazol had significantly lower rates of long-term mortality (11.5% vs. 13.4%, P < 0.001 and major amputation (4.0% vs. 4.7%, P = 0.022). However, there were no significant differences in rates of reintervention, major adverse limb events, or patency after PVI. Amputation-free survival rates were significantly higher for patients on cilostazol, after 4 years of follow up (89% vs. 87%, P = 0.03). CONCLUSIONS: Cilostazol is underutilized in the VQI database and seems to be associated with improved amputation-free survival. Cilostazol therapy should be considered in all patients with PAD who can tolerate it prior to PVI.

Arterial dissection during peripheral vascular interventions.

OBJECTIVE: Arterial dissection (AD) is a known complication of peripheral vascular interventions (PVIs), but its incidence and significance have not been well-characterized. This study examines AD in the Vascular Quality Initiative database for patients treated for peripheral arterial disease. Our hypothesis is that AD is associated with decreased patency and worse limb outcomes. METHODS: The Vascular Quality Initiative PVI registry (2016-2021) was reviewed. Patients were divided based on the presence or absence of reported AD during the procedure. Trend of incidence and management of AD was derived. The characteristics and outcomes of patients with and without AD were compared. The primary endpoint was primary patency. RESULTS: There was a total of 177,790 cases, and 3% had AD. The incidence of AD significantly increased over the study period from 2.4% to 3.6% (P = .007). Endovascular therapy was used to treat AD in 83.7% of cases, 14.5% were treated medically, and only 1.8% required open surgery. Patients with AD were significantly more likely to be female (47.4% vs 39.7%; P < .001). Patient with AD were more likely to have a history of smoking (79.7% vs 77.2%; P < .001), but were significantly less likely to be on dialysis (8.2% vs 9.3%; P < .001) compared with patients without AD. Patients with AD were more likely to have femoropopliteal disease (45.2% vs 38.0%; P < .001) and undergo treatment of more complex disease as denoted by higher mean number of lesions treated (1.95 ± 1.01 vs 1.71 ± 0.89; P < .001), longer occlusion length (8 ± 16 vs 7 ± 15 cm; P < .001), and more severe TransAtlantic Inter-Society Consensus grade (Grade D: 36.2% vs 29.1%; P < .001). The proportion of stenting as a treatment modality was higher in the dissection group (55.4% vs 41.1%; P < .001). After a mean follow-up of 828 days, patients with AD had significantly lower primary patency than patients without AD. Kaplan-Meier curves demonstrated that the AD group had lower primary patency (86.9% vs 91%; P < .001) and reintervention-free survival (79.5 % vs 84.1%; P < .001) at 1 year with difference in amputation-free survival. Cox proportional hazard regression confirmed the independent association of AD with primary patency and reintervention-free survival. CONCLUSIONS: AD is more common in women and is more likely to occur during treatment of the femoropopliteal segment. AD is associated with decreased primary patency and reintervention-free survival after PVI for peripheral arterial disease.

Prognostic properties of hypoalbuminemia in COVID-19 patients: A systematic review and diagnostic meta-analysis.

BACKGROUND: Coronavirus disease 2019 (COVID-19) elicits robust inflammatory reaction that may result in a declining albumin serum level. This meta-analysis aimed to evaluate the prognostic properties of hypoalbuminemia for poor prognosis and factors that may influence the relationship. METHOD: A systematic literature search of PubMed was conducted from inception to April 22, 2021. The main exposure was albumin level below normal range-defined by the included studies. The outcome of interest was composite poor outcome that comprises of mortality, severity, and the requirement of mechanical ventilation or intensive care unit. RESULTS: There were 6200 patients from 19 studies. Meta-analysis showed that hypoalbuminemia was associated with composite poor outcome (OR 6.97 (95% CI 4.20-11.55), p < 0.001; I2 = 91.3%, p < 0.001). Meta-regression analysis showed that age (p = 0.44), gender (p = 0.76), HT (p = 0.97), DM (p = 0.40), CKD (p = 0.65), liver disease (p = 0.72), and malignancy (p = 0.84) did not affect the association. Subgroup analysis showed that hypoalbuminemia increased mortality (OR 6.26 (95% CI 3.26-12.04), p < 0.001; I2 = 69.6%, p < 0.01) and severity of the disease (OR 7.32 (95%CI 3.94-13.59), p < 0.001; I2 = 92.5%, p < 0.01). Pooled diagnostic analysis of hypoalbuminemia yielded a sensitivity of 0.63 (95% CI 0.52-0.72), specificity of 0.81 (95% CI 0.73-0.87), and AUC of 0.77. The probability of poor outcome was 70% in patients with hypoalbuminemia and 24% in patients with normal albumin level. CONCLUSION: Hypoalbuminemia was associated with poor prognosis in COVID-19 patients.