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.

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 Impact of Ejection Fraction on Major Adverse Limb Events after Lower Extremity Revascularization.

BACKGROUND: Peripheral arterial disease (PAD) is commonly associated with coronary artery disease, and echocardiography is frequently performed before lower extremity revascularization (LER). However, the incidence of various echocardiographic findings in patients with PAD and their impact on the outcomes of LER has not been well studied. Reduced ejection fraction (EF) ≤ 40% is associated with increased major adverse limb events (MALE) after LER. METHODS: The electronic medical records of patients undergoing LER in a single center were reviewed. Patients were divided based on the presence or absence of reduced EF. Patient, transthoracic echocardiogram, procedural characteristics, and outcomes were compared between the 2 groups. RESULTS: A total of 1,114 patients (N = 131, 11.8% with reduced EF) underwent LER between 2013 and 2019. Patients with reduced EF were more likely to be male and have a history of coronary artery disease and heart failure. Furthermore, they were more likely to have diastolic dysfunction with moderate to severe mitral and tricuspid valve regurgitation. Patients with reduced EF were more likely to undergo LER for chronic limb-threatening ischemia, and to be treated with endovascular procedures. Perioperatively, patients with reduced EF were more likely to develop myocardial infarction. Lastly, the 2 groups had no difference in overall MALE or major amputation. However, on Kaplan-Meier curves, MALE-free survival was significantly lower for patients with reduced EF. Regression analysis demonstrated that indication and not EF was associated with MALE and MALE-free survival. CONCLUSIONS: Reduced EF is associated with decreased MALE-free survival for patients with PAD undergoing LER.

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.

Perioperative complications of minor and major reinterventions for peripheral arterial disease.

INTRODUCTION: Patients with peripheral arterial disease (PAD) frequently require reinterventions after lower-extremity revascularization (LER) to maintain perfusion. Current Society for Vascular Surgery guidelines define reinterventions as major or minor based on the magnitude of the procedure. While prior studies have compared primary LER procedures of different magnitudes, similar studies for reinterventions have not been performed. The objective of this study is to compare perioperative outcomes associated with major and minor reinterventions. METHODS: Patients undergoing LER for PAD at a tertiary care center from 2013 to 2017 were included. A retrospective review of electronic medical records was performed, and reinterventions were categorized as major or minor based on the procedure magnitude. Minor reinterventions included endovascular procedures and open revision with patch angioplasty, while major reinterventions were characterized by open surgical or endovascular LER with catheter-directed thrombolysis (CDT). Perioperative outcomes following LER were captured and compared for major and minor reinterventions. An additional subgroup analysis was performed comparing outcomes associated with major reinterventions stratified into open major surgical reinterventions and CDT. RESULTS: This study included 713 patients over a mean follow-up of 2.5 years. A total of 291 patients underwent 696 ipsilateral reinterventions (range = 1-12 reinterventions). Most reinterventions were minor (72.1%, N = 502) and 27.9% (N = 194) were major. Patients receiving reinterventions had an average age of 67.2 ± 11.5 and most were white (73.5%) males (60.1%) initially treated for claudication (58.2%) and CLTI (41.8%). There was significantly higher post-operative bleeding (9.8% vs 3.4%, p = .001), arterial thrombosis (3.1% vs 1.0%, p = .047), and acute renal failure (6.2% vs 2.4%, p = .014) after major reinterventions than minor. Additionally, major reinterventions had significantly higher return to the OR (17.0% vs 11.3%, p = .046) and longer hospital stays (7.5 vs 4.3 days, p = <.0001). Overall, major reinterventions were associated with significantly increased perioperative morbidity (37.6% vs 19.7%, p ≤ .001) with no difference in perioperative mortality. In the subgroup analysis, open reinterventions resulted in significantly longer hospital stays (8.6 days vs 5.5 days, p ≤ .001) and more wound infections than CDT (11.0% vs 0%, p = .017). However, there was no other significant difference in morbidity or mortality following treatment with open surgical reinterventions or CDT. CONCLUSIONS: In this study, major reinterventions after LER were associated with greater perioperative morbidity than minor reinterventions, with no difference in mortality. Major reinterventions performed via open surgery and CDT had similar morbidity and mortality.

Eligibility of Patients with Chronic Limb Threatening Ischemia for Deep Venous Arterialization.

BACKGROUND: Percutaneous deep venous arterialization (pDVA) has emerged as a new modality for limb salvage in patients with chronic limb threatening ischemia (CLTI) and no standard option for revascularization. The proportion of patients facing major amputation who are eligible for this technology remains unknown. This study aims to provide a real-life estimate of patient eligibility for pDVA to reduce major amputations. METHODS: Electronic medical records of 100 consecutive patients with peripheral arterial disease (PAD) who underwent major amputation of 106 limbs were reviewed. Angiograms performed ≤6 months before amputation were assessed by two vascular surgeons. Disease severity was categorized using the Global Limb Anatomic Staging System (GLASS) and patients were classified as ideal, possible, or not candidates for pDVA. Ideal candidates had ≥1 patent tibial artery, no target in the foot, and no proximal disease. Possible candidates had ≥1 patent tibial artery with PAD, no target in the foot, and proximal disease amenable to endovascular therapy. Patients were not eligible if there was no patent tibial artery, extensive PAD, or an arterial target in the foot for bypass. RESULTS: Of 106 limbs reviewed, 35 (33%) did not undergo angiography ≤6 months before amputation because of infection (n = 14), advanced tissue loss (n = 10), failed revascularizations (n = 8), advanced limb ischemia (n = 2), and refusing revascularization (n = 1). Thus, 69 lower extremity angiograms (2 incomplete excluded) in 68 patients were analyzed. A total of 15 patients with 16 limbs (23.2%) were identified as candidates for pDVA (ideal = 7, possible = 9). There were no differences in demographics between the two groups, but candidates for pDVA were less likely to have hyperlipidemia and congestive heart failure than those who were not candidates. The pDVA candidates underwent significantly fewer interventions before major amputation compared to patients who were not candidates (1.50 ± 0.73 vs. 2.61 ± 2.57, P = 0.007). Angiographically, patients who were pDVA candidates had significantly higher Inframalleolar GLASS grades (1.81 ± 0.40 vs. 0.86 ± 0.41, P < 0.0001) but lower Femoropopliteal Glass grades (0.73 ± 1.10 vs. 2.43 ± 1.71, P < 0.0001) than patients who were not candidates. There was no significant difference in GLASS stage between these two groups (P = 0.368). After mean follow-up of 48 months, there was no difference in mortality between both groups (40% vs. 32.1%, P = 0.567). CONCLUSIONS: Among patients considered for revascularization, 23.2% had favorable angiography and 14.7% could have benefited for pDVA as a new therapeutic modality for limb salvage. 33% of major amputations were performed for clinically-deemed unsalvageable CLTI.

The radiographic relationship of the femoral head, inguinal ligament, and common femoral artery bifurcation for optimal vascular access.

Objective: Common femoral artery (CFA) access is commonly used for endovascular interventions. Access site complications contribute to significant morbidity and mortality. This study characterizes the radiographic variability in the relationship of the femoral head, the inguinal ligament, and the CFA bifurcation, to identify the zone of optimal CFA access. Methods: Human cadaver dissection of the inguinal ligament and CFA bifurcation was performed. The inguinal ligament and CFA bifurcation were marked with radiopaque pins and plain anteroposterior radiographs were obtained. Radiographic measurements of the femoral head length, the distance of the top of the femoral head to the inguinal ligament, and to the CFA bifurcation were obtained. Results were reported as percentage of femoral head covered by the inguinal ligament or the CFA bifurcation relative to the top of the femoral head. A heatmap was derived to determine a safe access zone between the inguinal ligament and CFA bifurcation. Results: Forty-five groin dissections (male, n = 20; female, n = 25) were performed in 26 cadavers. The mean overlap of the inguinal ligament with the femoral head was 11.2 mm (range, -19.4 to 27.4 mm). There were no age (<85 vs ≥85 years) or sex-related differences. In 82.6% of cadaveric CFA exposures, there was overlap between the inguinal ligament and femoral head (mean, 27.7%; range, -85.7% to 70.1%), with 55.6% having a >25% overlap. In 11.1%, there was an overlap between the lower one-third of the femoral head and the CFA bifurcation. Cumulatively, heatmap analysis depicted a >80% likelihood of avoiding the inguinal ligament and CFA bifurcation below the midpoint of the femoral head. Conclusions: Significant variability exists in the relationship between the inguinal ligament, CFA bifurcation, and the femoral head, suggesting the lack of a consistently safe access zone. The safest access zone in >80% of patients lies below the radiographic midpoint of the femoral head and the inferior aspect of the femoral head.

Association of adherence to individual components of Society of Thoracic Surgeons cardiac surgery antibiotic guidelines and postoperative infections.

OBJECTIVES: The study objectives were to measure the association among the 4 components of Society of Thoracic Surgeons antibiotic guidelines and postoperative complications in a cohort of patients undergoing valve or coronary artery bypass grafting requiring cardiopulmonary bypass. METHODS: In this retrospective observational study, adult patients undergoing coronary revascularization or valvular surgery who received a Surgical Care Improvement Project-compliant antibiotic from January 1, 2016, to April 1, 2021, at a single, tertiary care hospital were included. The primary exposures were adherence to the 4 individual components of Society of Thoracic Surgeons antibiotic best practice guidelines. The association of each component and a combined metric was tested in its association with the primary outcome of postoperative infection as determined by Society of Thoracic Surgeons data abstractors, controlling for several known confounders. RESULTS: Of the 2829 included patients, 1084 (38.3%) received care that was nonadherent to at least 1 aspect of Society of Thoracic Surgeons antibiotic guidelines. The incidence of nonadherence to the 4 individual components was 223 (7.9%) for timing of first dose, 639 (22.6%) for antibiotic choice, 164 (5.8%) for weight-based dose adjustment, and 192 (6.8%) for intraoperative redosing. In adjusted analyses, failure to adhere to first dose timing guidelines was directly associated with Society of Thoracic Surgeons-adjudicated postoperative infection (odds ratio, 1.9; 95% confidence interval, 1.1-3.3; P = .02). Failure of weight-adjusted dosing was associated with both postoperative sepsis (odds ratio, 6.9; 95% confidence interval, 2.5-8.5; P < .01) and 30-day mortality (odds ratio, 4.3; 95% confidence interval, 1.7-11.4; P < .01). No other significant associations among the 4 Society of Thoracic Surgeons metrics individually or as a combination were observed with postoperative infection, sepsis, or 30-day mortality. CONCLUSIONS: Nonadherence to Society of Thoracic Surgeons antibiotic best practices is common. Failure of antibiotic timing and weight-adjusted dosing is associated with odds of postoperative infection, sepsis, and mortality after cardiac surgery.