Lower Extremity Revascularization Research Articles

Regional variation in lower extremity revascularization and amputation for peripheral artery disease

ObjectiveThe aim of this study was to quantify the recent and historical extent of regional variation in revascularization and amputation for peripheral artery disease (PAD). MethodsThis was a repeated cross-sectional analysis of all Ontarians aged 40 years or greater between 2002 and 2019. The co-primary outcomes were revascularization (endovascular or open) and major (above-ankle) amputation for PAD. For each of 14 health care administrative regions, rates per 100,000 person-years (PY) were calculated for 6-year time periods from the fiscal years 2002 to 2019. Rates were directly standardized for regional demographics (age, sex, income) and comorbidities (congestive heart failure, diabetes, chronic obstructive pulmonary disease, chronic kidney disease). The extent of regional variation in revascularization and major amputation rates for each time period was quantified by the ratio of 90th over the 10th percentile (PRR). ResultsIn 2014 to 2019, there were large differences across regions in demographics (rural living [range, 0%-39.4%], lowest neighborhood income quintile [range, 10.1%-25.5%]) and comorbidities (diabetes [range, 14.2%-22.0%], chronic obstructive pulmonary disease [range, 7.8%-17.9%]), and chronic kidney disease [range, 2.1%-4.0%]. Standardized revascularization rates ranged across regions from 52.6 to 132.6/100,000 PY and standardized major amputation rates ranged from 10.0 to 37.7/100,000 PY. The extent of regional variation was large (PRR ≥2.0) for both revascularization and major amputation. From 2002-2004 to 2017-2019, the extent of regional variation increased from moderate to large for revascularization (standardized PRR, 1.87 to 2.04) and major amputation (standardized PRR, 1.94 to 3.07). ConclusionsSignificant regional differences in revascularization and major amputation rates related to PAD remain after standardizing for regional differences in demographics and comorbidities. These differences have not improved over time.

Neutrophil-to-lymphocyte Ratio Is A Superior Prognostic Marker To Frailty In Patients Undergoing Open Lower Extremity Revascularization

Neutrophil-to-Lymphocyte ratio (NLR) is an easily obtained, low-cost marker of inflammation that has been shown to correlate with higher mortality and longer hospital stays in patients undergoing open lower extremity revascularization procedures. However, NLR has never been compared to other established risk calculators. We compared the prognostic value of NLR to the modified frailty index (mFI), a validated frailty metric.

Examining Care Fragmentation After PAD Interventions: The Readmission Event

Lower extremity revascularization (LER) for peripheral artery disease (PAD) is complicated by the frequent need for readmission either at the same facility or a different one than where the index LER was performed. Prior work using Vascular Quality Initiative data linked to Medicare claims has demonstrated that readmission rates after LER are 18% and 31% at 30 days and 90 days, respectively. It is unclear, however, if readmission at a nonindex LER facility compared with the index LER facility is associated with worse outcomes.

Anastomotic Stenosis with Thrombosis Due to Stump Syndrome During Lower Extremity Revascularization with Autovein Grafting

Anastomotic Stenosis with Thrombosis Due to Stump Syndrome During Lower Extremity Revascularization with Autovein Grafting

Is the use of direct anticoagulants justified after lower extremity revascularization surgery?

Is the use of direct anticoagulants justified after lower extremity revascularization surgery?

Impact of regional anesthesia on outcomes of geriatric patients undergoing lower extremity revascularization: A propensity score-matched cohort study.

Lower extremity revascularization (LER) for peripheral artery disease in elderly patients is associated with a high risk of perioperative morbidity and mortality. This study aimed to a conduct retrospective review and propensity score matching analysis to determine whether the use of regional anesthesia (RA) instead of general anesthesia (GA) in geriatric patients undergoing LER for peripheral artery disease results in improved short-term mortality and health outcomes. We reviewed medical records of 1271 patients aged >65 years who underwent LER at our center between May 1998 and February 2016. According to the anesthesia method, patients were grouped in the GA and RA groups. The primary outcome was short-term mortality (7-day and 30-day). The secondary outcomes were 5-year survival rate, intraoperative events, postoperative morbidity, and postoperative length of stay. A propensity score-matched cohort design was used to control for potentially confounding factors including patient demographics, comorbidities, American Society of Anesthesiologists physical status, and preoperative medications. After propensity score matching, 722 patients that received LER under GA (n = 269) or RA (n = 453) were identified. Patients from the GA group showed significantly higher 7-day mortality than those from the RA group (5.6% vs 2.7% P = .048); however, there was no significant difference in 30-day mortality between the groups (GA vs RA: 6.3% vs 3.6%, P = .083). The 5-year survival rate and incidence of arterial and central venous catheter placement or intraoperative dopamine and epinephrine use were significantly higher in the GA group than in the RA group (P < .05). In addition, the frequency of immediate postoperative oxygen therapy or mechanical ventilation support was higher in the GA group (P < .05). However, there was no difference in the postoperative cardiopulmonary and cerebral complications between the 2 groups. These results suggest that RA can reduce intraoperative hemodynamic support and provide immediate postoperative respiratory intensive care. In addition, the use of RA may be associated with better short-term and 5-year survival rates in geriatric patients undergoing LER.

Dual pathway inhibition for atherosclerotic cardiovascular disease: Recent advances.

Atherosclerotic cardiovascular disease (ASCVD), which includes coronary artery disease (CAD), cerebrovascular disease, and peripheral arterial disease (PAD) is associated with significant morbidity, mortality, and healthcare costs. Antiplatelet therapy has long been the mainstay of antithrombotic therapy for the prevention of first-ever and recurrent ASCVD events. More recently, however, randomized trials have demonstrated the benefits and cost-effectiveness of a dual pathway inhibition (DPI) strategy in acute and chronic ASCVD. When used in combination, aspirin and low-dose rivaroxaban work synergistically to inhibit platelet activation and thrombin generation, thereby preventing thrombus formation. Among patients with recent acute coronary syndrome (ACS), those with positive cardiac biomarkers or ST-segment elevation myocardial infarction, or a history of heart failure derive the greatest absolute benefits. Among patients with chronic ASCVD, those with involvement of two or more vascular beds, heart failure, chronic kidney disease, or diabetes derive the greatest absolute benefits. Additional trials are underway to assess the impact of DPI therapy in other populations of interest, including patients with ACS at high risk of left ventricular thrombus formation, intracranial atherosclerotic disease with recent transient ischemic attack or stroke, peripheral arterial disease with limiting claudication or post lower extremity revascularization, and advanced chronic kidney disease with ASCVD or risk factors for ASCVD. Further work is required to assess the possible added benefit of combining rivaroxaban with clopidogrel or ticagrelor instead of aspirin.

Keeping an eye on the diabetic foot: The connection between diabetic eye disease and wound healing in the lower extremity.

Diabetic eye disease is strongly associated with the development of diabetic foot ulcers (DFUs). DFUs are a common and significant complication of diabetes mellitus (DM) that arise from a combination of micro- and macrovascular compromise. Hyperglycemia and associated metabolic dysfunction in DM lead to impaired wound healing, immune dysregulation, peripheral vascular disease, and diabetic neuropathy that predisposes the lower extremities to repetitive injury and progressive tissue damage that may ultimately necessitate amputation. Diabetic retinopathy (DR) is caused by cumulative damage to the retinal mic-rovasculature from hyperglycemia and other diabetes-associated factors. The severity of DR is closely associated with the development of DFUs and the need for lower extremity revascularization procedures and/or amputation. Like the lower extremity, the eye may also suffer end-organ damage from macrovascular compromise in the form of cranial neuropathies that impair its motility, cause optic neuropathy, or result in partial or complete blindness. Additionally, poor perfusion of the eye can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy or neovascular glaucoma, both serious, vision-threatening conditions. Finally, diabetic corneal ulcers and DFUs share many aspects of impaired wound healing resulting from neurovascular, sensory, and immunologic compromise. Notably, alterations in serum biomarkers, such as hemoglobin A1c, ceruloplasmin, creatinine, low-density lipoprotein, and high-density lipoprotein, are associated with both DR and DFUs. Monitoring these parameters can aid in prognosticating long-term outcomes and shed light on shared pathogenic mechanisms that lead to end-organ damage. The frequent co-occurrence of diabetic eye and foot problems mandate that patients affected by either condition undergo reciprocal comprehensive eye and foot evaluations in addition to optimizing diabetes management.

Use of Thromboelastography with Platelet Mapping to Identify Prothrombotic Coagulation Profiles in Patients with History of Cardiac Intervention Undergoing Lower Extremity Revascularization.

Patients with concomitant coronary and peripheral artery disease (CAD and PAD) are at significant risk for major adverse limb events (MALEs). Prevention of thrombosis in this population is of paramount importance. Identifying prothrombotic coagulation profiles in this cohort may facilitate targeted thromboprophylaxis. We compared coagulation profiles of those with CAD and PAD to those with PAD alone during the perioperative period of lower extremity revascularization. Patients undergoing lower extremity revascularization underwent thromboelastography-platelet mapping (TEG-PM) analysis preoperatively and at serial intervals for up to 6 months. Coagulation profiles of patients with significant CAD (defined as history of coronary artery bypass graft or percutaneous coronary intervention) and PAD were compared with those with PAD alone. MALE in the postoperative period was recorded. Four hundred seventy-seven TEG-PM samples from 114 patients were analyzed; 28.1% had a history of significant CAD. The incidence of atrial fibrillation was higher in this group. The significant CAD group had lower ADP-platelet inhibition, higher ADP-platelet aggregation, and greater maximum clot strength compared with patients with PAD alone. Patients with significant CAD were more frequently on full-dose anticoagulation, but less frequently on dual antiplatelet therapy; 28.1% of patients with significant CAD developed postoperative MALE compared with 22.9% of patients with PAD alone (p = 0.40). For both groups, patients who developed postoperative MALE demonstrated greater ADP-platelet aggregation and lower ADP-platelet inhibition. Patients with a history of significant CAD undergoing lower extremity revascularization demonstrated prothrombotic TEG-PM profiles, less frequent use of dual antiplatelet therapy, and greater rates of full-dose anticoagulation. Decreased platelet inhibition was also associated with postoperative MALE. This study underscores the potential utility of viscoelastic assays for coagulation profiling in complex cardiovascular patients.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits

BackgroundPatients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. MethodsIn the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician’s discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. ResultsAmong 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. ConclusionsSurgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Role of Prophylactic Sartorius Flaps for Preventing Deep Space Infection in Lower Extremity Revascularization.

Groin infections in vascular surgery are common and compromise the goal of limb preservation. Strategies to prevent deep space infection(DSI) include incision orientation and muscle flaps. Literature evaluating prophylactic flaps preventing DSIis scarce. We aimed to compare prophylactic sartorius flaps to layered closure in preventing readmission for DSI, along with the effect of incision orientation. This was a retrospective study of vascular surgery patients at a single institution with femoral artery exposure from 2017-2021. Patients with active groin infections were excluded. Prophylactic sartoriusflaps were compared to those with layered closure regarding 30-day hospital readmission for DSI. Oblique versus vertical incisions wascompared regarding the primary outcome. Fifty-three patients received sartorius flaps, and 122 received layered closure. Seventy patients had oblique incisions, and 105 patients had vertical incisions. Sartorius flaps had a higher rate of previous groin surgery compared to layered closure (45.3% vs. 24.7%, p<0.01). Vertical incisions had a higher rate of previous groin surgery (38.1% vs. 20.0%, p<0.02), while oblique incisions had a higher rate of obesity (24.3% vs. 8.6%, p<0.01). There was a lower rate of DSI in sartorius flaps compared to layered closure (1.9% vs. 6.6%, p=2.80), although not statistically significant due to lack of power. There wasno difference in DSI in the oblique versus vertical incisions (4.3% and 5.7%, p=0.760). Patients with prophylactic sartorius flaps experienced fewer DSI, although further evaluation with increased sample size is required for adequate study power. We believe sartorius flaps are a simple solution to prevent groin complications.

Predictors of Major Adverse Limb Events After Infrainguinal Bypass in Patients with Diabetes

ObjectiveDiabetes mellitus is a major risk factor for peripheral artery disease (PAD). The association of diabetes with major adverse limb events (MALE) after lower extremity revascularization (LER) remains controversial as patients with diabetes are often analyzed as a homogenous group. This study examines the impact of insulin use and glucose control on the outcomes of infrainguinal bypass. Our hypothesis is that insulin therapy and hemoglobin A1c (A1c) are predictors of MALE and might be used to stratify outcomes in of LER in patients with diabetes. MethodsThe Vascular Quality Initiative (VQI) database for infrainguinal bypass (2007-2021) was reviewed. Patients with diabetes undergoing bypass for PAD were included. Patients on dialysis or with kidney transplant were excluded. The characteristics and outcomes of patients with insulin requiring diabetes mellitus (IRDM) were compared with patients not requiring insulin (NIRDM). ResultsA total of 9,686 patients with diabetes (56% IRDM) underwent bypass. Patients with IRDM were significantly younger than patients with NIRDM and more likely to be female, African American, and Hispanic. After a mean follow-up of 427 days post-operation, patients with IRDM had significantly lower primary patency and higher major amputation, MALE, and mortality. (Table) Regression analyses demonstrated that insulin use, but not A1c, was independently associated with higher risk of MALE (HR = 1.17 [1.06-1.29]) and mortality (HR=1.28 [1.16-1.43]). ConclusionPrevalent insulin use, but not the degree of A1c control, is a significant predictor of MALE and survival after infrainguinal bypass and should be used to stratify the outcomes of LER in patients with diabetes.

Use of Recanalized Vessels for Diabetic Foot Reconstruction: Pushing the Boundaries of Reconstruction in a Vasculopathic Lower Extremity.

Free flap after lower extremity revascularization may enable limb salvage in defects after critical limb ischemia. This study examined the outcomes of reconstruction of ischemic diabetic foot according to the severity of the vessel occlusion and assessed whether recanalized vessels may serve as a reliable recipient vessel. A total of 62 patients who underwent diabetic foot reconstruction with free flaps after successful percutaneous transluminal angioplasty (PTA) from February of 2010 to February of 2016 were identified and divided into three groups: group 1, nonoccluded vessels as recipient ( n = 11); group 2, recanalized artery after PTA for partially occluded artery ( n = 30); and group 3, recanalized artery after PTA for completely occluded artery ( n = 21). Flap survival was statistically higher in group 2 (90%) compared with group 3 (67%) ( P < 0.05). Subsequent major amputation was significantly lower in groups 1 and 2 [0/7 and 1/30 (3.3%)] compared with group 3 [5/21 (23.8%)] ( P < 0.05). The patient survival and limb salvage rate was 90.9% at 1 and 3 years in group 1, 89.8% at 1 year and 86.3% at 3 and 5 years in group 2, and 76.2% at 1, 3, and 5 years in group 3. This difference was not statistically significant ( P = 0.485). The use of recanalized vessels after PTA can be safe for partially occluded arteries but requires caution for completely occluded arteries. Using completely occluded vessels after PTA can be attempted when other options are not available and achieves a 76% chance of limb salvage. Therapeutic, III.

Impact of socioeconomic disparities on major lower extremity revascularization complications.

Low socioeconomic status (SES), distance lived from hospital, and insurance status are well documented in the literature to increase the risk of post-operative morbidity and mortality for some disease processes however there is a paucity of data regarding how this association impacts patients with peripheral artery disease (PAD). This study aimed to evaluate if SES, distance lived from hospital, and insurance status increased the risk of developing major graft failure in patients undergoing revascularization procedures for symptomatic PAD in a prospective, observation study. In this prospective, observational study, all patients undergoing lower extremity revascularization (endovascular or open) were included from December 2020 to February 2022. Demographic factors, insurance status, operative details, and median income and distance from hospital were documented through chart review. Complications were defined as thrombosis/occlusion of the revascularized vessel or bypass graft or infection of the distal wound or surgical incision wound. Univariate and multivariate analysis were performed comparing patients that developed complications and those that did not. This project was undertaken at the Massachusetts General Hospital and was governed by the Institutional Review Board (IRB: 2020P000263) all patients agreed to participation via informed written consent prior to enrollment in the study. A total of 108 patients were enrolled in the study of which 94 underwent successful revascularization procedures. Of those 94 patients, 38 (40.4%) underwent open bypass, 39 (41.5%) underwent endovascular revascularization, and 17 (18.1%) underwent a hybrid approach. There were no significant differences in post-operative outcomes between operative approaches. Twenty-five patients (28.7%) experienced major revascularization complications as defined as re-occlusion of the treated vessel/thrombosis of the bypass graft (n = 13) or development of post-operative infection (n = 12). There was no significant difference in median income ($75,295 vs $87,757, p = NS), distance lived from hospital, (27.4 miles vs. 29.7 miles, p = NS), or type of insurance (private 24% vs 26%, government 76% vs 73%, p = NS between patients that experienced complications versus those that did not have complications. These findings suggest the risk of major graft failure is independent of a patient's socioeconomic status, distance lived from hospital, or insurance type in patients undergoing revascularization procedures for PAD. While socioeconomic factors impact access to and have a known association with negative outcomes, complications in patients with PAD appear to be independent of these factors. To mitigate the negative outcomes in patients with peripheral artery disease, a focus should be on patient risk factors and modifiable medical factors that contribute to adverse outcomes.

Predicting Arterial Thrombotic Events Following Peripheral Revascularization Utilizing Objective Viscoelastic Data

Background Peripheral artery disease (PAD) is endemic in our globally aging population with >200 million affected worldwide. Graft/stent thrombosis after revascularization is common and frequently results in amputation, major adverse cardiovascular events, and cardiovascular mortality. Optimizing medications to decrease thrombosis is of paramount importance, however limited guidance exists on how to utilize and monitor therapy in this heterogeneous population. Thromboelastography with Platelet Mapping (TEG-PM) provides comprehensive coagulation metrics and may be integral to the next stage of patient-centered thrombophrophylaxis. This prospective study aimed to determine if TEG-PM could predict subacute graft/stent thrombosis following lower extremity revascularization and if objective cut-point values could be established that were associated with graft thrombosis. Methods We conducted a single-center prospective observational study on patients undoing lower extremity revascularization within the vascular surgery department. Patients were enrolled over a two year period between December 2020-May 2022, underwent preoperative and serial postoperative TEG-PM analysis at 10 timepoints (pre, peri, post operative), and were followed for up to one year. The primary outcome was a composite endpoint of graft/stent thrombosis requiring reintervention or amputation. Cox proportional hazards (PH) regression analysis examined the association of thrombosis and TEG-PM metrics. Cut-point analysis explored the predictive capacity of TEG-PM metrics for thrombosis and were based on the Youden index. Results A total of 144 patients were analyzed, of which 29 (20.1%) experienced graft/stent thrombosis. Patients who developed thrombosis had statistically greater % platelet aggregation [80.6±15.1 vs. 58.9±25.3] and statistically lower % platelet inhibition [19.8±15.0 vs. 40.8±25.4] (all p<0.01) compared to those who did not (Figure1). Cox PH analysis revealed that for every 1% increase in platelet aggregation, the hazard of experiencing an event during the study period increased by 5% [HR= 1.05, 95% CI 1.03-1.08, p<0.01]. An optimal cut-point of >70.8% platelet aggregation or <29.2% platelet inhibition identifies those at high risk of thrombosis with 90.0% sensitivity. Conclusions Among patients undergoing lower extremity revascularization, increased platelet reactivity, found on point-of-care viscoelastic technology, was predictive of subacute postoperative graft/stent thrombosis. Based on the cut-points of >70.8% platelet aggregation and <29.2% platelet inhibition, consideration of an alternative or augmented antithrombotic regimen for high risk patients may decrease the risk of postoperative thrombotic events.Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Abstract 10889: Unplanned Limb Revascularization With Rivaroxaban versus Placebo in Patients With Critical Limb Ischemia After Endovascular and Surgical Treatment: Insights From Voyager Pad

Introduction: Patients with critical limb ischemia (CLI) have a class I indication for lower extremity revascularization (LER) by either endovascular or surgical approach. A common complication is recurrent arterial occlusion requiring unplanned index limb revascularization (UILR). VOYAGER PAD established the efficacy of rivaroxaban in patients with symptomatic peripheral artery disease (PAD) after successful LER, including a reduction in UILR. Whether this benefit differs by LER approach for CLI is unknown. Hypothesis: Rivaroxaban reduces UILR regardless of LER approach for CLI. Methods: LER indication (CLI or claudication) and approach were captured at baseline. The primary composite endpoint was acute limb ischemia, major vascular amputation, MI, ischemic stroke or CV death. TIMI major bleeding was the primary safety outcome. UILR was a prespecified secondary outcome. A Cox proportional-hazards model was used to calculate hazard rations and 95% confidence intervals. Results: Among 6,564 participants randomized , 1,533 (23%) had CLI, of whom 696 (45%) and 837 (55%) underwent surgical and endovascular LER, respectively. CLI patients on rivaroxaban had fewer events at three years compared to those on placebo (HR 0.85). Efficacy of rivaroxaban for the primary endpoint (p-interaction 0.40) and safety (p-interaction 0.18) in CLI were consistent regardless of approach. On background therapy (aspirin in all, statins ~80%, DAPT ~50%), at a median of 28 months, UILR occurred in 26.2% and 14.3% after endovascular and surgical LER, respectively. Rivaroxaban significantly reduced UILR by 22% in patients with CLI (HR 0.78, p=0.019, Figure), with consistent benefits in those treated with endovascular and surgical LER (p-interaction 0.70). Conclusions: CLI patients have high rates of UILR after LER. Rivaroxaban reduced the rate of UILR in this population, regardless of endovascular or surgical approach.

Abstract 12311: The Impact of Ejection Fraction on Major Adverse Limb Events After Lower Extremity Revascularization

Objective: Peripheral arterial disease (PAD) is commonly associated with cardiac disease and echocardiography is frequently performed prior to lower extremity revascularization (LER). However, the incidence of various echocardiographic findings and their impact on the outcomes of LER have not been well studied. Hypothesis: Low ejection fraction (EF) ≤ 40% is associated with increased major adverse limb events (MALE) after LER. Methods: The electronic records of patients undergoing LER in a single center were reviewed. Patients were divided based on the presence or absence of reduced EF ≤ 40%. Patient, echocardiographic, and procedural characteristics were compared as well as outcomes. Results: A total of 1,034 patients (N=130, 12.5% with EF≤ 40%) underwent LER. Patients with reduced EF were more likely to be males, with coronary artery disease and heart failure. On echocardiography, patients with reduced EF had significantly higher mean right ventricular pressure and were more likely to have diastolic dysfunction. Moderate to severe regurgitation affecting the mitral and tricuspid valves were significantly higher in patients with reduced EF. There was no difference in indication but patients with reduced EF were more likely to be treated with endovascular procedures. Perioperatively, patients with reduced EF were more likely to develop myocardial infarction. (Table) There was no difference in MALE or major amputation between the 2 groups but MALE-free survival was significantly lower for patients with EF≤ 40%. (Figure). Conclusion: Reduced EF is associated with decreased survival of patients with PAD after LER but does not seem to significantly impact MALE.

Abstract 10240: Lower May Not Be Better: Systolic Blood Pressure and Risk of Major Adverse Limb Events in Patients With Symptomatic Peripheral Artery Disease After Revascularization: Insights From Voyager Pad

Introduction: Blood pressure (BP) trials have established optimal targets for major adverse cardiovascular event (MACE) prevention; however, less intensive BP control (also called permissive hypertension) is sometimes utilized to minimize end organ damage in specific settings such as acute stroke and acute kidney injury. An analysis from ALLHAT found that systolic blood pressure (SBP) &lt;120mmHg was associated with a 26% higher rate of major adverse limb events (MALE) in peripheral artery disease (PAD). Whether this association is present in patients with PAD after lower extremity revascularization (LER) is not well described. Methods: VOYAGER PAD randomized patients with symptomatic PAD after LER to rivaroxaban or placebo. The primary composite endpoint was time to first event of MACE or MALE. BP measurements were obtained at baseline, 1, 3, and every 6 months after enrollment. Associations between average SBP at 1 month after LER and incident MACE and MALE through follow up were evaluated. Splines were estimated in proportional hazard models with adjustment for treatment assignment. Results: SBP measurements at 1 month were available in 6,248 patients. Median (IQR) SBP in mmHg was (126, 114-139). The relationship between SBP after LER and future risk of MACE (Figure, Panel A) shows an apparent increased risk at SBP &lt;90mmHg. The relationship of SBP and MALE appeared linear (Figure, Panel B) with a lower risk at higher SBP and greater risk with SBP below ~120mmHg. For every 5mmHg decrease in SBP there was an associated 7% increase in risk of MALE (HR 1.07, 95% CI 1.05-1.10, p &lt;0.0001). The pattern appeared consistent regardless of index revascularization type (surgical vs endovascular). Conclusion: Patients with PAD are at heightened risk of MALE due to obstructive conduit artery disease. There is an inverse relationship between SBP and MALE after LER. Further investigation into optimal BP targets in patients with PAD are warranted.

Abstract 14535: Association Between Lower Extremity Revascularization Reinterventions and Treating Facility on Limb Preservation

Introduction: Lower extremity revascularization (LER) improves quality of life and limb preservation rates. However, LER is complicated by the frequent need for short-term reintervention (re-LER). It is unclear if re-LER at a facility that did not perform the initial revascularization is associated with subsequent amputation. Hypothesis: Re-LER at a non-index procedural site is associated with 90-day major amputation. Methods: This was a national cohort study of older adults who underwent endovascular LER for PAD with subsequent re-LER (January 1, 2010 - December 31, 2018) in the Vascular Quality Initiative dataset linked to CMS claims and American Hospital Association facility-level data. We excluded acute limb ischemia and aneurysm procedural indications. The primary outcome was 90-day amputation. The primary exposure was site of first re-LER (same or different than index site). Multivariable logistic regression was used to determine the association between patient and facility characteristics and the likelihood of 90-day amputation. Results: Among 4,473 patients, 60.6% were male and 82.5% were White. One-fifth of patients had their re-LER at a non-index procedural site. Chronic limb threatening ischemia (CLTI) was the operative indication in 52.9%, 44.2% were on the femoropopliteal segment, and 64.8% of index LER procedures were completed in the outpatient setting. Comparing those who had re-LER at a non-index versus index procedural site, there were no differences in age or sex. However, a higher proportion of Black patients had their first re-LER at a non-index site (16.0% vs 13.7%, p=0.01). After adjusting for patient characteristics, re-LER at a non-index facility was associated with a 34% increase in the odds of amputation (odds ratio [OR] 1.34 [95% CI 1.02-1.75]). Additionally, non-White race was also associated with increased odds of amputation (OR 1.40 [95% CI 1.06-1.84]). After adjusting for facility characteristics, these differences were no longer significant. Conclusions: Disease-specific factors appear to be associated with the likelihood of amputation after re-LER while sociodemographic and facility-level factors do not. Quality improvement efforts should focus on early identification and management of patients with PAD.

Abstract 12197: Causes of Death in Patients With Symptomatic Peripheral Artery Disease After Lower Extremity Revascularization: Insights From Voyager Pad

Background: In trials of patients with coronary artery disease (CAD), unknown deaths (e.g. out of hospital) are often categorized as sudden/presumed cardiovascular (CV) based on observations that recurrent coronary events are a major cause of mortality. Such conventions are applied broadly to CV trials, including those in peripheral artery disease (PAD). Recent trials in patients selected on the basis symptomatic PAD, such as EUCLID trial, report that only ~1/3 have known CAD. Therefore, understanding the causes of death in patients in trials of symptomatic PAD may help elucidate whether different conventions should be considered. Hypothesis and Methods: VOYAGER PAD enrolled patients with symptomatic PAD after lower extremity revascularization. Source documents were collected for all deaths and cause was adjudicated by an independent blinded CEC using accepted CV trial conventions for those dying out of hospital. For this post-hoc analysis, source documents were re-reviewed to provide further details regarding specific causes of deaths. Results: 6564 patients were randomized and followed for a median of 28 months. A total of 637 deaths occurred, and of these, 35% were CV, 22% were unknown (e.g. out of hospital, sudden deaths), and 43% were non-CV. Of the CV deaths, 40% (14% of all deaths) were atherothrombotic (e.g. acute MI, stroke, PE), while 60% (21% of all deaths) were not atherothrombotic (e.g. heart failure, shock). Deaths due to cancer (17%) and infection (15%) were more frequent than atherothrombotic deaths. Conclusions: Patients recruited into trials for symptomatic PAD die of diverse causes. Atherothrombosis caused a minority of deaths, while heart failure, cancer, and infection are as or more frequent. These observations suggest that causes of death differ in populations selected on the basis of PAD versus CAD and that assumptions underlying categorization of deaths of unknown etiology should be carefully considered in these distinct populations.