Infrainguinal Endovascular Intervention Research Articles

Endovascular Management of Chronic Limb-Threatening Ischemia (CLTI) in the Elderly: A Focus on Frailty, Wound Healing, and Outcomes

In India, a significant scarcity of published data exists regarding chronic limb-threatening ischemia (CLTI) and its management, especially among the elderly population. CLTI, often accompanied by frailty poses a significant healthcare challenge. While endovascular interventions offer hope, there remains a dearth of outcome data for this age group. This study seeks to address this critical gap by investigating the impact of frailty on outcomes, emphasizing amputation-free survival (AFS), wound healing, and health-related quality of life (HRQoL). Our study included 131 elderly CLTI patients aged ≥70 years who underwent infrainguinal endovascular interventions between April 2018 and August 2021, with a follow-up period of 2 years. Among the patients, 93.9% had diabetes mellitus and 82.4% had hypertension. Clinical frailty was assessed using the Clinical Frailty Scale (CFS). Patients were categorized into Group 1 (CFS 1-5) and Group 2 (CFS 6-9). Primary outcomes were AFS, wound healing, HRQoL, and their association with frailty. Secondary outcomes included technical success, procedure-related complications, major adverse limb events (MALE), major adverse cardiovascular events (MACE), vessel patency, re-intervention rates, and mortality rates including peri-procedural and overall mortality. Technical success was achieved in 86.3% of patients, with frailty significantly influencing this outcome. Group 2 exhibited reduced technical success (80.8%) compared to Group 1 (93.1%). The major amputation rate was 9.2%, with higher rates in Group 2 [univariate Hazard Ratio (HR): 5.20; p=0.033]. Similarly, Group 2 showed elevated overall mortality [univariate HR: 5.18; p < 0.001]. AFS at 1 and 2 years were 67.9% and 55% respectively, with higher rates in Group 1. Wound healing was achieved in 76.1% of patients (83/109), with frailty significantly associated with delayed wound healing (p < 0.001). Vessel patency at 1 year was observed in 88.8% of patients. HRQoL significantly improved post-intervention, with VascuQol-6 scores increasing from an average of 9 of 24 at baseline to 20 of 24 at 2 years. Frailty score significantly correlated with VascuQol-6 scores at 1 and 2 years (p < 0.0012). Group 1 exhibited higher VascuQol-6 scores compared to Group 2, indicating improved HRQoL during follow-up. Successful endovascular treatments in high-risk CLTI patients promote improved wound healing and post-treatment quality of life (QoL). Frailty should be assessed before endovascular interventions as it correlates with adverse outcomes, including amputations and mortality. While revascularization holds promise, caution is advised for frailer patients, emphasizing the importance of personalized care and tailored treatments for elderly CLTI patients.

Validation of the global limb anatomical staging system in Vietnamese patients treated for chronic limb-threatening ischemia

BackgroundChronic limb-threatening ischemia (CLTI) is the most severe clinical form of peripheral artery disease (PAD), accounting for approximately 11%, and is strongly associated with the incidence of amputation, cardiovascular events, and mortality. The Global Vascular Guideline (GVG) proposed a new Global Anatomic Staging System (GLASS) for evaluating the anatomic complexity of arterial lesions. However, more research is required to evaluate outcomes after endovascular intervention in CLTI patients using the GLASS.ObjectiveOur study aimed to describe clinical characteristics, arterial lesions, and endovascular interventions according to three grades of GLASS in the Vietnamese population. We evaluated the technical success, mortality rate, and probability to preserve the limb according to the GLASS.MethodsAll patients were diagnosed with CLTI and underwent infrainguinal endovascular intervention at the Department of Thoracic and Vascular Surgery, University Medical Center, Ho Chi Minh City from June 2020 to June 2022. All patients were evaluated before intervention and follow-up at 6 and 12 months after intervention. Patients were divided into three groups according to the GLASS, thereby comparing the technical success, mortality, and amputation rates. This retrospective study describes a series of cases.ResultsThe study sample evaluated 82 lower limbs of 82 patients, in which GLASS class I, II, and III lesions accounted for 36.6%, 43.9%, and 19.5% of the patients, respectively. The rates of technical success in the groups gradually decreased according to the complexity of the lesions (90%, 86.11%, and 56.25% for GLASS I, II, and III, respectively; p = 0.012). Notably, limb-based patency (LBP) at 12 months was significantly lower in the GLASS III group than in the GLASS I and II groups (22.22% vs 88.89% and 67.74%, respectively; p = 0.001). The amputation rates at 12 months in GLASS groups I, II, and III were 13.3%, 22.2%, and 50%, respectively (p = 0.021), while the mortality rates at 12 months were 0%, 8.33%, and 25%, respectively (p = 0.015).ConclusionIn patients with CLTI of higher GLASS stages, the rates of technical success were lower and the amputation and mortality rates were higher.

Percutaneous, Antegrade Access of the Superficial Femoral Artery can be Safely Used in Procedures for the Treatment of Lower Extremity Limb Ischemia

Recent studies have shown that antegrade access for treatment of infrainguinal peripheral vascular disease is associated with decreased radiation exposure and contrast use without a significant increase in access complication, although data is limited on antegrade superficial femoral artery (SFA) access for larger sheath sizes. We aim to describe a single institution's contemporary experience with percutaneous antegrade SFA access. A retrospective review of percutaneous, infrainguinal endovascular interventions for arterial occlusive disease at a major academic institution was conducted between 2018 and 2020. Antegrade, percutaneous, SFA access cases were included. Information on demographics, indication, sheath size, arteries treated, type of intervention, concurrent pedal access, closure devices, and complications was collected and analyzed. A total of 45 patients with an average BMI of 25.25 were identified. Indications for intervention included tissue loss (64.4%), rest pain (6.7%), claudication (13.3%), and acute limb ischemia (11.1%). 80.0% of patients had multilevel interventions. Angioplasty was performed in 68.8% of patients, stenting in 8.3%, atherectomy in 15.6% and thrombectomy in 7.3%. Nearly a quarter of cases involved concurrent pedal access. Maximum sheath size was 4Fr for 4.4% of patients, 5Fr for 28.9%, 6Fr for 46.7%, 7Fr for 11.1%, and 8Fr for 8.9%. Closure device was utilized in 75.6% of cases, with no closure device failures. In the entire cohort, there were no demonstrated access site complications. This study demonstrates percutaneous, antegrade SFA access for complex endovascular interventions for infrainguinal occlusive disease can be effectively utilized, even with larger sheath size. Moreover, routine use of closure devices is safe, improving patient comfort and expediting time to ambulation.

Risk stratification with explainable machine learning for 30-day procedure-related mortality and 30-day unplanned readmission in patients with peripheral arterial disease.

Predicting 30-day procedure-related mortality risk and 30-day unplanned readmission in patients undergoing lower extremity endovascular interventions for peripheral artery disease (PAD) may assist in improving patient outcomes. Risk prediction of 30-day mortality can help clinicians identify treatment plans to reduce the risk of death, and prediction of 30-day unplanned readmission may improve outcomes by identifying patients who may benefit from readmission prevention strategies. The goal of this study is to develop machine learning models to stratify risk of 30-day procedure-related mortality and 30-day unplanned readmission in patients undergoing lower extremity infra-inguinal endovascular interventions. We used a cohort of 14,444 cases from the American College of Surgeons National Surgical Quality Improvement Program database. For each outcome, we developed and evaluated multiple machine learning models, including Support Vector Machines, Multilayer Perceptrons, and Gradient Boosting Machines, and selected a random forest as the best-performing model for both outcomes. Our 30-day procedure-related mortality model achieved an AUC of 0.75 (95% CI: 0.71-0.79) and our 30-day unplanned readmission model achieved an AUC of 0.68 (95% CI: 0.67-0.71). Stratification of the test set by race (white and non-white), sex (male and female), and age (≥65 years and <65 years) and subsequent evaluation of demographic parity by AUC shows that both models perform equally well across race, sex, and age groups. We interpret the model globally and locally using Gini impurity and SHapley Additive exPlanations (SHAP). Using the top five predictors for death and mortality, we demonstrate differences in survival for subgroups stratified by these predictors, which underscores the utility of our model.

Interpretable Machine Learning for the Prediction of Amputation Risk Following Lower Extremity Infrainguinal Endovascular Interventions for Peripheral Arterial Disease.

Severe peripheral artery disease (PAD) may result in lower extremity amputation or require multiple procedures to achieve limb salvage. Current prediction models for major amputation risk have had limited performance at the individual level. We developed an interpretable machine learning model that will allow clinicians to identify patients at risk of amputation and optimize treatment decisions for PAD patients. We utilized the American College of Surgeons National Surgical Quality Improvement Program database to collect preoperative clinical and laboratory information on 14,444 patients who underwent lower extremity endovascular procedures for PAD from 2011 to 2018. Using data from 2011 to 2017 for training and data from 2018 for testing, we developed a machine learning model to predict 30day amputation in this patient population. We present performance metrics overall and stratified by race, sex, and age. We also demonstrate model interpretability using Gini importance and SHapley Additive exPlanations. A random forest machine learning model achieved an area under the receiver-operator curve (AU-ROC) of 0.81. The most important features of the model were elective surgery designation, claudication, open wound/wound infection, white blood cell count, and albumin. The model performed equally well on white and non-white patients (Delong p-value = 0.189), males and females (Delong p-value = 0.572), and patients under age 65 and patients age 65 and older (Delong p-value = 0.704). We present a machine learning model that predicts 30day major amputation events in PAD patients undergoing lower extremity endovascular procedures. This model can optimize clinical decision-making for patients with PAD.

Importance of the profunda femoris upon patency following aortoiliac procedures

ObjectiveThe importance of the profunda femoris for aortoiliac inflow procedure patency is well-recognized. We aim to quantify the characteristics of the profunda femoris and its relation to patency following aortoiliac inflow procedures. MethodsPatients undergoing aortoiliac inflow procedures between 2009 and 2019 were identified. These were classified into aorto-bifemoral bypass (ABF), extra-anatomic bypass (EAB), femoral endarterectomy (FEA), and iliac stenting. Preoperative imaging characteristics of the profunda femoris were reviewed as well as outcomes. ResultsWe performed 269 procedures in 202 patients. Of these, 162 were men (59.8%), with a mean age of 61 years (standard deviation, 11.45 years). A total of 123 patients (45.3%) presented with claudication, 69 (25.9%) with critical limb ischemia, and 30 (11.2%) with acute limb ischemia. Fifty patients (18.6%) underwent ABF, 44 (16.4%) underwent EAB, 57 (21.2%) underwent FEA, and 158 (58.7%) underwent iliac stenting. Fourteen patients (5.2%) underwent FEA plus iliac stenting. Fifty-two patients (19.2%) had an occluded superficial femoral artery. Twenty-four patients (8.9%) had additional outflow procedures performed during the index operation, including infrainguinal endovascular intervention in 10 patients (3.7%), infrainguinal bypass in 10 patients (3.7%), and femoropopliteal thrombectomy in 5 patients (1.9%). The mean follow-up was 17.5 months with overall 2-year primary patency (PP) of 79%. Two-year PP was 94.7% for FEA, 85.6% for ABF, 79.8% for iliac stents, and 62.5% for EAB. Unadjusted analysis revealed that loss of primary assisted patency was associated with active smoking (67.6% vs 48.6%; P = .035), lower creatinine (mean, 0.84 vs 1.06 mg/dL; P = .003), critical limb ischemia vs claudication (37.8% vs 21.4%; P = .037), and profunda femoris with fewer than five branches >2 mm in size (88.2% vs 68.5%; P = .011). Multivariate analysis confirmed that a profunda with five or more branches >2 mm in diameter was significantly associated with a lower risk of thrombosis (odds ratio, 0.30; P = .034). Size of the profunda greater than 6 mm approached statistical significance on univariate analysis (35% of the non-thrombosed vs 21% in the thrombosed; P = .073), but did not significantly affect risk of thrombosis on the multivariate analysis (odds ratio, 0.58; P = .25). The 2-year PP when all operations were considered was 76% compared with 72% for profunda with fewer than five branches > 2 mm. ConclusionsAnatomic characteristics of the profunda are associated with patency of inflow procedures. Care should be taken to assess the main profunda and branch diameters on preoperative imaging. A concomitant infrainguinal procedure should be considered in cases of profunda with inadequate large branches, to ensure long-term patency of the inflow operation.

Retrospective Validation of Global Limb Anatomic Staging System with Respect to Technical Failures in Endovascular Infrainguinal Revascularization for Critical Limb Threatening Ischemia

Introduction: The Global Vascular Guidelines proposed the Global limb anatomic staging system (GLASS) to overcome the shortcomings of previous multiple classification system. It grades the infrainguinal disease into three stages with a specific algorithm to score the femoropopliteal and tibial segments. We aim to retrospectively validate the GLASS staging in primary endovascular therapy with respect to immediate technical failures (ITFs). Materials and Methods: Retrospective data from November 2017 to September 2021 were collected from the existing clinical database. All patients who underwent primary infrainguinal endovascular intervention for critical limb-threatening ischemia were included in the study. The patient who had isolated infrapopliteal disease without a named tibial outflow and only inframalleolar disease were excluded. The GLASS scoring was applied to the angiographic details in the database. The ITFs from the database were compared to the predicted technical failure according to GLASS staging. Statistical analysis was done. Results: Hundred thirty-two patients were studied from clinical database. We had 13 (9.8%) ITFs. None of those in GLASS Stage I had failure. Among 26 patients in Stage II, 1 (4%) had failure, against the predicted failure rate of lesser than 20%. Among 89 patients in GLASS Stage III, only 12 (13.5%) had failures against the predicted failure rate of more than 20%. The majority of failures had occurred in higher GLASS staging. Conclusion: Higher failures in higher GLASS staging have been validated by our study. However, it is limited considering the small cohort and retrospective analysis.

Abstract No. 162 The effect of preprocedural renal failure on outcomes following infrainguinal endovascular arterial interventions

Abstract No. 162 The effect of preprocedural renal failure on outcomes following infrainguinal endovascular arterial interventions

Insulin-Dependent Status Influences Post-Procedural Outcomes in Diabetic Patients Following Lower Extremity Endovascular Intervention for Peripheral Arterial Disease.

Diabetic patients are at increased risk of developing lower extremity peripheral arterial disease (PAD) requiring revascularization. This study assessed the effect of insulin dependence in diabetics on post-procedural outcomes following infra-inguinal endovascular intervention. The American College of Surgeon's National Surgical Quality Improvement Program database was used to identify 8022 patients undergoing infra-inguinal endovascular interventions between 2014 and 2017. Thirty-day post-procedural outcomes for patients without diabetes, with non-insulin-dependent diabetes mellitus (NIDDM), and with insulin-dependent diabetes mellitus (IDDM) were compared. At presentation, IDDM patients were more likely to present with critical limb ischemia compared to NIDDM and non-diabetic patients. In propensity score-weighted logistic regression analysis, IDDM status was an independent predictor for increased renal complication (odds ratio [OR] = 3.08, confidence interval [CI] = 1.44-6.65), sepsis (OR = 1.68, CI = 1.13-2.48), wound complication (OR = 1.57, CI = 1.09-2.25, p = 0.006), UTI (OR = 2.07, CI = 1.09-3.94, p = 0.03), and readmission (OR = 1.21, CI = 1.03-1.42). NIDDM status was an independent predictor for increased risk of renal complications (OR = 2.80, CI = 1.18-6.63). IDDM status is an independent predictor for increased risk of 30-day post-procedural complications and readmission compared to both NIDDM and non-diabetic status in patients undergoing lower extremity endovascular interventions for PAD.

Comparison between antegrade common femoral artery access and superficial femoral artery access in infrainguinal endovascular interventions

BackgroundAntegrade access for infrainguinal endovascular intervention can be achieved through the common femoral artery (CFA) or superficial femoral artery (SFA). A few studies with small sample sizes have shown similar efficacy and safety for antegrade puncture of the CFA and SFA. In the present study, we analyzed the feasibility of SFA access and the occurrence of complications between SFA and CFA ipsilateral access in a broader cohort. MethodsIn the present retrospective study, we analyzed data from 462 patients with peripheral arterial disease (PAD) who had undergone peripheral angioplasty from 2009 to 2016. The inclusion criteria were PAD at Rutherford stage 3 to 6 and use of an endovascular approach. Patients with coagulation disorders, those receiving anticoagulant therapy, cases with deployment of closure devices, cases with more than one access on the same limb, and patients with inadequate bed rest after the procedure were excluded. A systematic analysis of all patients' electronic medical records was performed to evaluate the demographic aspects and technical success and identify the possible complications associated with CFA and SFA access. ResultsOf the 462 patients, 290 had undergone SFA puncture and 172, CFA puncture. The demographic evaluation of both groups revealed no differences between the two groups, except that more patients with diabetes were in the CFA group and more patients with dyslipidemia and an advanced clinical presentation were in the SFA group. First puncture access was successful in 99.7% of the SFA group and 96.5% of the CFA group (P = .01). The hematoma rate in the SFA and CFA groups was 20.3% and 11%, respectively (P = .01). The incidence of major bleeding and clinically relevant nonmajor bleeding was not significantly different between the two groups (P = .215). Only three patients had developed a pseudoaneurysm, two of whom were in the SFA group. Female sex (odds ratio [OR], 2.572; 95% confidence interval [CI], 1.520-4.354; P < .001] and older age (OR, 1.034; 95% CI, 1.009-1.059; P = .007) were associated with an increased hematoma rate. ConclusionsSFA access was associated with a higher overall rate of hematoma compared with CFA access. However, no significant difference was found in the incidence of major bleeding between the two access sites. Planned SFA access should be considered as an alternative to CFA access.

The Effect of Preoperative Renal Failure on Outcomes Following Infrainguinal Endovascular Interventions for Peripheral Arterial Disease

PurposeTo analyze the effect of a patient’s renal failure status on acute outcomes after lower extremity endovascular interventions for peripheral artery disease. Materials and MethodsA retrospective analysis of the American College of Surgery National Surgical Quality Improvement Program database from 2014 to 2017 was conducted. Patients were included based on current procedural terminology codes. They were divided into renal failure cohorts. Six thousand seven hundred and sixty-five patients were included in the analysis, 11.0% of whom had renal failure. A univariate analysis was performed using chi-squared test or Fischer’s exact test as appropriate. Multivariate logistic regression models were constructed, while controlling for relevant patient factors, to identify the effect of renal failure on several outcomes of interest after the intervention. A sensitivity analysis was performed with a propensity score-matched cohort. ResultsPatients with renal failure were more likely to have infrapopliteal interventions (38.0% vs 20.9%), critical limb ischemia with tissue loss (73.5% vs 38.9%), diabetes (70.9% vs 52.3%), preoperative wound infection (59.2% vs 30.7%), mortality (5.1% vs 1.3%), prolonged hospital stay (68.5% vs 46.5%), transfusion after the intervention (13.3% vs 9.1%), reoperation (18.3% vs 9.5%), and readmission (24.9% vs 12.6%), compared to patients without renal failure. The multivariate analysis found renal failure to be significant for mortality (odds ratio [OR] = 4.11, 95% confidence interval [CI] = 2.71–6.24), any complication (OR = 2.03, 95% CI = 1.72–2.39), extended length of stay (OR = 1.53, 95% CI = 1.28–1.83), sepsis (OR = 2.37, 95% CI = 1.60–3.51), readmission (OR = 1.89, 95% CI = 1.57–2.29), reoperation (OR = 1.84, 95% CI = 1.48–2.27), major adverse cardiovascular event (OR = 3.50, 95% CI = 2.54–4.84), and major adverse limb event (OR = 1.97, 95% CI = 1.55–2.51). P value was <.001 unless otherwise noted. ConclusionsRenal failure before the intervention places patients at a significantly elevated risk of morbidity and mortality following endovascular revascularization procedures for peripheral artery disease.

Unplanned readmissions after endovascular intervention or surgical bypass for critical limb ischemia

ObjectiveAfter surgery or other interventions, unplanned readmissions are associated with poor outcomes and drain health care resources. Patients with critical limb ischemia (CLI) are at particularly high risk of readmission, and readmissions result in increased health care costs. The primary aims of the study were to discover and compare the 30-day readmission rates of patients who underwent lower extremity surgical bypass (LEB) and endovascular infrainguinal endovascular intervention (IEI) for CLI and to evaluate the relationship between unplanned readmissions likely related to the primary procedure for IEI compared with LEB. MethodsThe Targeted Vascular Module from the American College of Surgeons National Surgical Quality Improvement Program was queried to identify all infrainguinal LEB or IEI for CLI from 2015 to 2018. Those who were not eligible for the primary outcome of interest were excluded. The primary 30-day outcome was unplanned readmission. Univariate analyses for primary and secondary outcomes were performed using Fisher's exact and Wilcoxon rank-sum testing. Multivariate analysis was performed using inverse probability weighting and independent risk factors for readmission were identified with logistic regression. ResultsThere were 12,873 patients who met inclusion criteria. In the LEB cohort, there were 7270 (56.5%) patients, and in the IEI cohort, there were 5603 (43.5%) patients. Thirty percent (n = 1696) of the IEI cohort underwent a tibial intervention, and 49% (n = 3547) underwent a distal bypass. The IEI cohort was more likely to be high physiologic risk (P < .001) and to present with tissue loss (P < .001), whereas the LEB cohort was more likely to have high anatomic risk features (P < .001) and be performed under emergent conditions (P < .001). After multivariable analysis, LEB was found to be independently predictive for both unplanned readmissions due to any cause (adjusted odds ratio, 1.35; 95% confidence interval, 1.22-1.51; P < .001) and procedure-related unplanned interventions (adjusted odds ratio, 1.85; 95% confidence interval, 1.63-2.11; P < .001). Independent predictors of readmission were LEB, preoperative sepsis, severe chronic kidney disease, dependent functional status, insulin-dependent diabetes mellitus, high-risk physiologic features, African American race, preoperative steroid use, history of severe chronic obstructive pulmonary disease, and preoperative tissue loss. ConclusionsLEB is independently associated with unplanned readmission from all causes and from procedure-related causes after adjusting for the measured confounders. More research is required to determine the economic burden of these readmissions.

Endovascular 30-day Outcomes for Critical Limb Ischemia Are Improving in Recent Years Relative to Surgical Bypass Grafting

Data from 2011 to 2014 have shown lower extremity bypass (LEB) to outperform infrainguinal endovascular intervention (IEI) regarding major adverse limb events (MALEs) but noted no significant difference in major adverse cardiac events (MACE) in propensity matched cohorts. This study aimed to determine if more recent (2015-2018) endovascular outcomes data have improved compared to surgical bypass. The Targeted Vascular Module from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) was queried to identify patients undergoing endovascular intervention for critical limb ischemia from 2015 to 2018. The cohort was categorized as being a LEB or IEI. Primary 30-day outcomes included MACE, MALEs, and major amputation. Univariate analyses were performed using the χ2 test and the Wilcoxon rank-sum test. Multivariate analysis was performed using inverse probability weights. A total of 13,200 patients were identified who underwent an infrainguinal intervention for CLI from 2015 to 2018: 7489 (56.7%) underwent LEB and 5711 (43.3%) underwent IEI. In this cohort, 37.6% were considered high anatomic risk, and 30.5% were considered high clinical risk. Median age was 68 years (interquartile range, 60-76 years). The IEI cohort versus the LEB cohort experienced a myocardial infarction/stroke rate of 2.3% versus 4.0% (P < .001), had a mortality rate of 2.5% versus 2.1% (P = .16), and a composite MACE of 4.3% versus 5.5% (P = .001). The reintervention rate for IEI versus LEB was 4.6% versus 5.5% (P = .01), loss of patency (no reintervention) rate was 1.7% versus 1.9% (P = .6), and major amputation rate was 5.0% versus 4.2% (P = .04), resulting in a composite MALE of 10.0% versus 9.6% (P = .46). When only high anatomic risk patients (IEI vs LEB) were considered (n = 4967), MACE was noted in 3.8% versus 5.2% (P = .02), MALE was noted in 12.2% versus 11.1% (P = .25) and amputation rates were 5.2% versus 4.9% (P = .53). When only high clinical risk patients were considered (n = 4019), MACE was experienced in 7.3% versus 9.9% (P = .003), MALE by 10.9% versus 10.3% (P = .54) and amputation by 5.6% versus 5.1% (P = .53). After inverse probability weighting, comparing the IEI to the reference LEB, MALE (adjusted odds ratio [AOR], 1.06; 95% confidence interval [CI], 0.94-1.20), MACE (AOR, 0.64; 95% CI, 0.54-0.76), and major amputation (AOR, 1.1; 95% CI, 0.95-1.3). Endovascular outcomes no longer demonstrate inferiority in MALE or major amputation. Endovascular intervention has a significantly reduced incidence of MACE. These results demonstrate an improvement in endovascular MACE, MALE and amputation rates in recent years relative to surgical bypass.

Larger Sheath Size for Infrainguinal Endovascular Intervention Is Associated With Minor but Not Major Morbidity or Mortality

Infrainguinal peripheral vascular interventions (PVIs) can be performed with a variety of sheath sizes. Our aim was to investigate the effect of sheath size on postprocedural complications after infrainguinal PVIs. The Vascular Quality Initiative (2010-2017) was queried for patients undergoing infrainguinal PVIs via retrograde common femoral artery access. Univariable and multivariable methods were performed to compare the effects of sheath size on access site complications, length of stay (LOS), and 30-day mortality. Of the 36,901 infrainguinal PVI procedures in the data set, the mean age was 69years, and 59.1% of patients were male. Indications for intervention were claudication (41.6%), rest pain (13.2%), and tissue loss (45.2%). The femoropopliteal and tibial arteries were treated in 84.7% and 35.4% of cases, respectively. Interventions included stenting (39.2%) and atherectomy (21.3%). Sheath sizes of 7F, 6F, 5F, and 4F were used in 5225 (14.1%), 24,541 (66.5%), 6221 (16.9%), and 914 (2.5%) cases, respectively. Differences among sheath sizes were observed based on the ambulatory status; presence of diabetes, end-stage renal disease, previously stented ipsilateral extremities, anemia, preprocedural anticoagulation; and procedural details including indications, location of intervention, and intervention type (P<0.001 for all). On univariable analysis, sheath size (7F vs 6F vs 5F vs 4F) was associated with differences in access site hematoma (3.5% vs 2.7% vs 2.5% vs 1.2%, P<0.001), postprocedural LOS>1day (18.1% vs 25.3% vs 31.1% vs 27.9%, P<0.001), and 30-day mortality (0.9% vs 1.4% vs 1.5% vs 1.5%, P=0.007). There was no difference in hematoma requiring intervention or access site stenosis/occlusion based on sheath size. Multivariable analysis revealed that a larger sheath size was independently associated with access site hematoma (7F: odds ratio [OR] = 4.24, 95% confidence interval [CI] = 2.28-7.89, P<0.001; 6F: OR = 3.11, 95% CI = 1.69-5.7, P<0.001; 5F: OR = 2.72, 95% CI = 1.46-5.05, P=0.002) and postprocedural LOS>1day (7F: OR = 1.69, 95% CI = 1.39-2.05, P<0.001; 6F: OR = 1.5, 95% CI = 1.26-1.78, P<0.001; 5F: OR = 1.51, 95% CI = 1.26-1.8, P<0.001). Access site hematoma requiring intervention and 30-day mortality were not independently associated with sheath size. In infrainguinal PVIs, larger sheaths increased the risk of minor access site hematomas, but not major morbidity or mortality. Larger sheaths were associated with longer postprocedural LOS, possibly because of conservative management of hematomas.

IP189. Larger Sheath Size for Infrainguinal Endovascular Intervention Is Associated With Minor Access Site Hematomas and Longer Length of Stay

IP189. Larger Sheath Size for Infrainguinal Endovascular Intervention Is Associated With Minor Access Site Hematomas and Longer Length of Stay

SU97EFFECT OF PHARMACOGENETICS-GUIDED ANTIDEPRESSANT TREATMENT ON SUICIDAL IDEATION

Infrainguinal revascularization for disabling claudication (DC) is frequently performed, but long-term results are still unknown. In this study, we compared clinical outcomes of infrainguinal endovascular (EV) and open interventions for DC after the failure of medical management.One hundred ninety-four patients with DC (Rutherford category 3) who had open (n = 53) or EV (n = 141) interventions were grouped as open–great saphenous vein (GSV) (n = 21), open-prosthetic (n = 32), EV-Trans-Atlantic Inter-Society Consensus II (TASC II) A and B (AB) (n = 48), and EV-TASC II C and D (CD) (n = 93). Patency, primary clinical success (PCS; sustained improvement in symptoms without reintervention), and secondary clinical success (SCS; sustained improvement in symptoms with reintervention) rates were compared.Mean follow-up was 57 ± 33 months. Five-year primary patency was 58% in open-GSV, 40% in open-prosthetic, 72% in EV-AB, and 38% in EV-CD (P < 0.001). Five-year secondary patency was 77% in open-GSV, 50% in open-prosthetic, 96% in EV-AB, and 61% in EV-CD (P < 0.001). Freedom from major adverse limb events was 73% in open-GSV, 77% in EV-AB, 70% in EV-CD, and 67% in open-prosthetic (P = 0.279). Five-year PCS was 46% in open-GSV, 40% in open-prosthetic, 57% in EV-AB, and 44% in EV-CD (P = 0.02). Five-year SCS was 78% in open-GSV, 78% in open-prosthetic, 85% in EV-AB, and 84% in EV-CD (P = 0.732). A total of 116 reinterventions were performed, 10 in 6 limbs (27%) in open-GSV, 18 in 12 limbs (36%) in open-prosthetic, 26 in 15 limbs (24%) in EV-AB, and 62 in 39 limbs (36%) in EV-CD. Reinterventions included 71 (61%) EV and 45 (39%) open procedures.Durability of infrainguinal interventions in claudicants depends mainly on anatomic complexity of disease. Good long-term clinical success can be achieved with both open and EV interventions, albeit with high reintervention rates, especially in patients with TASC II C and D disease. A considerable subset of EV patients will eventually require surgical revascularization to maintain clinical benefit. In this study, almost 20% of patients undergoing EV for TASC II C and D disease eventually required surgical bypass.

Atherectomy-assisted versus percutaneous angioplasty interventions for treatment of symptomatic infra-inguinal peripheral arterial disease.

IntroductionThe role of atherectomy (ATHERO) for the treatment of symptomatic infra-inguinal arterial lesions remains controversial. We evaluated the effectiveness and safety of atherectomy-assisted endovascular interventions in comparison with percutaneous angioplasty (PTA).Material and methodsA systematic search utilizing MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials was conducted for studies comparing ATHERO with PTA from February 1995 to May 2018. Only studies comparing ATHERO to PTA for symptomatic infra-inguinal disease were included. Random-effects meta-analysis was used to pool the data and endpoints across studies. Study endpoints included vessel dissection, distal embolization, residual stenosis (> 30%), vessel patency at 6 months, target lesion revascularization (TLR) at 12 months and major amputation rates at 1, 6, and 12 months.ResultsA total of 2923 patients were included from 8 studies. PTA was associated with higher vessel dissection (OR = 4.00, 95% CI: 1.15–13.86) and lower 12-month major amputation rates (OR = 0.73, 95% CI: 0.59–0.90). There was no significant difference between ATHERO and PTA groups in terms of distal embolization (OR = 0.45, 95% CI: 0.04–4.63), residual stenosis (OR = 1.28, 95% CI: 0.58–2.80), vessel patency at 6 months (OR = 1.27, 95% CI: 0.50–3.22), TLR at 12 months (OR = 1.07, 95% CI: 0.46–2.51), or limb amputation at 1 month (OR = 0.69, 95% CI: 0.44–1.07) or 6 months (OR = 1.54, 95% CI: 0.38–6.15).ConclusionsIn patients undergoing infra-inguinal endovascular interventions, PTA was associated with higher peri-procedural vessel dissection and lower 12-month major amputation rates. Both modalities were associated with similar distal embolization, residual stenosis, and 6-month vessel patency and amputation rates.

Preoperative beta blockade is associated with increased rates of 30-day major adverse cardiac events in critical limb ischemia patients undergoing infrainguinal revascularization

ObjectiveThe association between beta blockers and cardiovascular or limb-related outcomes after revascularization for critical limb ischemia (CLI) remains unclear. The objective of this study was to assess the impact of preoperative beta blockade on 30-day major adverse cardiac events (MACEs) and major adverse limb events (MALEs) in patients undergoing infrainguinal revascularization for CLI. We hypothesized that rates of MALEs and MACEs will be higher in patients not receiving preoperative beta blockade. MethodsThe National Surgical Quality Improvement Program vascular targeted file for 2011 to 2014 identified patients receiving beta blockade and undergoing infrainguinal endovascular intervention and open bypass for CLI. Primary outcomes including 30-day MACE (stroke, myocardial infarction [MI], or death) and MALE (untreated loss of patency, reintervention, or amputation) were compared between patients taking and not taking preoperative beta blockers. Multivariate logistic regression identified independent predictors of MACEs and MALEs. ResultsA total of 11,785 revascularizations were performed for CLI during the study period (7408 bypasses vs 4377 endovascular interventions). Preoperative beta blockers were used by 7365 patients, including 4541 (61.7%) in the open bypass cohort and 2824 (64.5%) in the endovascular group (P < .01). MACEs and MI were significantly higher in patients with preoperative beta blockers (MACEs, 5.8% vs 3.4% [P < .0001]; MI, 3.1% vs 1.8% [P < .0001]). After controlling for cardiac risk factors, beta blockers independently predicted MACEs (odds ratio [OR], 1.27; P = .03) and MI (OR, 1.36; P = .03) but not stroke (OR, 1.17; P = .58) or 30-day mortality (OR, 1.22; P = .19). Beta-blocker use did not have an effect on MALEs (OR, 0.99; P = .88). ConclusionsIn patients with CLI, preoperative beta blockade was an independent predictor of 30-day MI and MACEs after controlling for other cardiovascular risk factors. Beta blockers did not have an impact on short-term limb-related outcomes. The association between beta blockade and revascularization for CLI deserves further investigation.

Major adverse limb events and major adverse cardiac events after contemporary lower extremity bypass and infrainguinal endovascular intervention in patients with claudication

ObjectiveMajor adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) at 30 days provide standardized metrics for comparison and have been adopted by the Society for Vascular Surgery's objective performance goals for critical limb ischemia. However, MALEs and MACEs have not been widely adopted within the claudication population, and the comparative outcomes after lower extremity bypass (LEB) and infrainguinal endovascular intervention (IEI) remain unclear. The purpose of this study was to compare MALEs and MACEs after LEB and IEI in a contemporary national cohort and to determine predictors of MALEs and MACEs after revascularization for claudication. MethodsA national data set of LEB and IEI performed for claudication was obtained using National Surgical Quality Improvement Program vascular targeted Participant Use Data Files from 2011 to 2014. Patients were stratified by LEB vs IEI and compared by appropriate univariate analysis. The primary outcomes were MALE (defined as untreated loss of patency, reintervention on the index arterial segment, or amputation of the index limb) and MACE (defined as stroke, myocardial infarction, or death). Multivariable logistic regression was used to identify predictors of MALEs and MACEs. ResultsA total of 3925 infrainguinal revascularization procedures (2155 LEB and 1770 IEI) were performed for claudication. There was no difference in 30-day MALEs between LEB and IEI (4.0% vs 3.2%; P = .17). On multivariable logistic regression, predictors of 30-day MALEs included tibial revascularization (odds ratio [OR], 2.2; P < .0001) and prior LEB on the same arterial segment (OR, 1.8; P = .004). LEB had significantly higher 30-day MACEs (2.0% vs 1.0%; P = .01) but similar mortality (0.5% vs 0.4%; P = .6). Predictors of MACEs included LEB vs IEI (OR, 2.1; P = .01), chronic obstructive pulmonary disease (OR, 2.2; P = .01), dialysis dependence (OR, 4.4; P = .003), and diabetes (OR, 1.9; P = .02). ConclusionsIn this large national cohort, LEB and IEI for claudication are associated with similar 30-day MALEs. Tibial revascularization and revascularization after prior failed bypass predict MALEs in claudicants and should therefore be undertaken with caution. LEB was associated with more 30-day MACEs but comparable 30-day mortality compared with IEI. Patients with end-stage renal disease, chronic obstructive pulmonary disease, and diabetes are at high risk for MACEs. The risk of 30-day MACEs after LEB should be weighed against the longer term outcomes of LEB vs IEI and conservative management, particularly in these higher risk patients. This analysis helps define contemporary 30-day outcomes after infrainguinal revascularization performed for claudication and serves as a baseline with which the short-term outcomes of future treatments can be compared.

Invited commentary

Invited commentary